Food Safety and Inspection Service, USDA.
Final rule.
The Food Safety and Inspection Service (FSIS) is issuing regulations to limit the amount of water retained by raw, single-ingredient, meat and poultry products as a result of post-evisceration processing, such as carcass washing and chilling. Raw livestock and poultry carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses and parts is an inevitable consequence of the process used to meet applicable food safety requirements. In addition, the establishment will be required to disclose on the labeling of the meat or poultry products the maximum percentage of retained water in the raw product. The required labeling statement will help consumers of raw meat and poultry products to make informed purchasing decisions. Establishments having data demonstrating that there is no retained water in their products can choose not to label the products with the retained-water statement or to make a no-retained-water claim on the product label.
FSIS is also revising the poultry chilling regulations to improve consistency with the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) regulations, eliminate “command-and-control” features, and reflect current technological capabilities and good manufacturing practices.
Submit one original and two copies of written comments to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102, 300 12th Street, SW., Washington, DC 20250–3700. Please refer to docket number 97–054F in your comments. All comments submitted on this rule, as well as the research and background information used by FSIS in developing this document, will be available for public inspection in the Docket Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday through Friday. The final regulatory impact analysis referred to in this document and summarized in the section discussing the Agency's compliance with Executive Order 12866 is available for viewing on the Agency's Internet homepage located at
Ms. Patricia F. Stolfa, Assistant Deputy Administrator, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250–3700; (202) 205–0699.
FSIS carries out the mandates of the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601
Under the Acts (21 U.S.C. 601(m)(8); 453(g)(8)), a product is adulterated if, among other circumstances in which it might be adulterated, “any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.” Under the same Acts (21 U.S.C. 601(n)(1), (12) and 21 U.S.C. 453(h)(1), (12)) a product is misbranded if, among other circumstances in which it might be misbranded, “its labeling is false or misleading in any particular.”
FSIS provides continuous inspection in meat and poultry slaughtering and processing establishments and in egg product processing plants to ensure that the establishments sell in commerce only products that are not adulterated or misbranded. At meat and poultry slaughtering establishments, FSIS enforces requirements intended to prevent the adulteration of carcasses and parts during post-evisceration processing, handling, and storage. Some of these requirements concern the washing and chilling of the carcasses and parts.
After evisceration, raw livestock and poultry carcasses are subject to various processes, including washing and chilling, to ensure the safety of the products. In livestock slaughtering establishments, air chilling causes carcass weight loss from evaporation of the natural water in the carcass during evaporative cooling. Spraying water on livestock carcasses during air chilling either replaces the water that would have evaporated during air chilling or prevents the water in the carcass from evaporating. The result is that livestock carcasses subjected to a water spray do not lose weight through evaporation. Establishments should operate water spray systems in a manner that does not result in an increase in the average weight of a group of livestock carcasses produced during a scheduled period of operations over the carcasses' pre-chilled weight. FSIS Directive 6330.1, which describes the Agency's policies on the spray-chilling of carcasses, recognizes that it is technologically feasible and commercially practical to chill livestock carcasses in a manner that, on average, does not result in an increase in the carcass weight above the pre-chilled weight.
However, the processing and chilling methods used for some edible meat byproducts and organ meats may result in water retention. For example, cheek meat, meat from ears and tails, and organ meats are washed, cleaned, and chilled to preserve safety and wholesomeness before being shipped. Chitterlings (swine intestines) are washed and chilled before shipment and are packaged with water. A few establishments chill beef cheek meats in water, a process that may result in the absorption of water. The product is labeled to indicate the maximum percentage added water it may contain to alert buyers to the fact that the product may weigh more because of the chilling process.
Unlike meat packers, poultry processors have traditionally chilled poultry using the water-immersion chilling method. Although air chilling is permitted, immersion chilling is more rapid and cost efficient. The use of water immersion chilling is limited to whole poultry carcasses or major carcass portions. Poultry establishments are required to reduce the internal temperature of water-chilled poultry carcasses to 40 °F or less within 4 to 8 hours after slaughter, depending on the size of the carcass (9 CFR 381.66(b)).
Chilling poultry carcasses in water-immersion chillers always results in some absorption and retention of water, primarily in the skin and the tissue immediately under the skin. Also, some water becomes bound to the muscle tissue.
FSIS has consistently required that the retention of water in meat and poultry products be minimized. FSIS is mandated to prevent the distribution in commerce of meat, meat food and poultry products that are adulterated or misbranded.
Immersion chilling of poultry could result in a product becoming misbranded or economically adulterated through the retention of absorbed water. Nonetheless, since immersion chilling is an efficient way to control bacterial growth in poultry products and to ensure that establishments consistently meet applicable chilling time and temperature requirements, FSIS has permitted the retention of some water in poultry products. The Agency requires, however, that retained water amounts be minimized (9 CFR 381.66(d)(1)) and has set limits on the amount of water a poultry product may retain (9 CFR 381.66(d)(2)–(4)).
The Agency promulgated regulations limiting water absorption and retention in poultry products in 1959, 1961, and 1970 (24 FR 9566, December 1, 1959; 26 FR 6471, July 19, 1961; 35 FR 15739, October 7, 1970). The retained-water limits were based on carcass weight and intended use of the product. For example, higher limits were provided for birds that were to be cut-up than for those to be sold as whole birds because, when the birds are cut up, water retained at or near those higher limits declines below the regulatory limits for whole birds. If water has not been minimized, the product may be considered adulterated. Such product may also be considered misbranded if its labeling does not disclose the presence of retained water at levels higher than the required limits. Until a Federal court set aside the regulatory limits on retained water in poultry products, public knowledge of the limits obviated the need for a requirement for retained water to be disclosed on a product label. Without published limits on retained water, FSIS cannot adequately protect consumers from adulteration and misbranding due to excessive retained water in whole birds.
FSIS, however, lacks information on which to decide what level, if any, of retained water would not constitute adulteration, or to determine whether the limits that are in use do not result in adulteration.
On September 11, 1998, FSIS proposed regulations that would limit the amount of water retained by raw carcasses and parts of livestock and poultry as a result of post-evisceration processing, such as carcass washing and chilling. Under the proposal, meat and poultry carcasses and parts could not retain water from such processing unless the establishment preparing the carcasses and parts demonstrated that water retention is an unavoidable consequence of procedures necessary to meet applicable food safety requirements. FSIS also proposed to require that the establishment disclose on the product labeling the maximum percentage of retained water in the product. The labeling statement would provide information that would be helpful to consumers in making purchasing decisions. An establishment having data demonstrating that there is no retained water in the products could choose not to label the products with the retained-water statement or to make a no-retained-water claim on the product label. The proposed requirements were intended to replace those set forth in 9 CFR 381.66(d)(2)–(8). The purpose of the proposed requirements was to restrict, as much as feasible, the amount of water absorbed and retained in raw meat and poultry products.
The proposed rule was prompted by longstanding industry petitions and by the Agency's need to reform its regulations to make them more consistent with its Pathogen Reduction/Hazard Analysis and Critical Control Point System (PR/HACCP) regulations, in accordance with its regulatory reform agenda. The rulemaking gained further impetus in the wake of a July 23, 1997, Federal court decision in
As explained above, FSIS has consistently required that the retention of water in meat and poultry be minimized and has considered product with too much retained water to be adulterated. FSIS used the retained water limits specified in § 381.66(d)(2) to determine whether poultry establishments were meeting the requirement to minimize water absorption and absorption and retention in whole birds. The decision in
FSIS is aware that it may be difficult to eliminate water retention for poultry and some meat products while continuing to meet applicable food safety requirements. Even in operations that yield raw product with zero-percent retained water, there is a certain amount of process variability. FSIS therefore proposed an alternative to a zero-percent retained-water requirement. Establishments would be required to collect data, in accordance with a protocol approved by FSIS, and demonstrate that water retention is an unavoidable consequence of the process used to meet a food safety requirement, such as the
FSIS said in the proposal that it would accept data generated from an approved protocol to support water retention levels for multiple establishments using similar post-evisceration processing techniques and equipment. Depending on the design of the protocol and the adequacy of the data collected under it, the Agency stated that the data could be used to justify an industry-wide water-retention limit, a limit applying to poultry products processed by several establishments, or a limit applying only to a single establishment's product. Establishments using an industry-wide or multi-establishment limit would have to be able to demonstrate that the conditions under which their products
FSIS received 252 letters commenting on the proposed rule. Most were from members of the regulated industry. Sixty-one were from companies, company officials, or other individuals associated with the meat industry, or trade associations representing the industry, including both producers and packers. One hundred and sixty-nine were from companies, company officials or other individuals associated with the poultry industry, or from trade associations representing the industry, including both producers and processors. The rest were sent in by consumer-advocacy groups and other consumer-oriented organizations (3), individual consumers (7), weights and measures officials (7), a trade association not exclusively concerned with meat and poultry (1), technology firms (3), and the European Union. Consumers, consumer groups, and commenters representing livestock producer and meat packing interests tended to favor the proposal or to criticize it for not going far enough in restricting water retention. Poultry interests tended to oppose the proposal or to favor extensive modifications. Technology firms were divided on the merits of the proposal and on processes for improving food safety.
Comment summaries (each termed “Comment”) by topic and Agency responses follow:
On the other side, poultry groups said that the proposal does not treat poultry equitably with meat. They said that the meat industry uses spray chilling and does not have to adhere to chilling time/temperature requirements as does the poultry industry. Moreover, they said, organ meats are chilled in water without regulatory limitation.
Poultry groups also suggested that the proposed regulations may not apply equally to livestock and poultry parts. They said that “parts” in the meat regulations has a connotation different from that of “parts” in the poultry regulations. They asserted that there are few proposed changes that would affect the chilling and labeling of meats.
The point of the poultry industry commenters with respect to the spray chilling of meat carcasses is well taken, and it is true that meat carcasses do not have to meet chilling time/temperature requirements as do poultry carcasses.
FSIS acknowledges the need to address the issue involving the chilling time and temperature requirements for poultry that were raised in both the American Meat Institute's 1997 petition and industry comments on this rulemaking. However, as the Agency indicated in the preamble to the proposed rule (63 FR 48963, 48965), FSIS did not intend to address this issue in this but in a future rulemaking.
FSIS does not agree with the poultry industry statement about the meaning of “parts” in the meat and poultry regulations, nor does the Agency see the relevance of the point to this rule. Raw, single-ingredient meat and poultry products, including parts of either meat or poultry carcasses, are covered. Some products of the meat industry that previously have not been covered by a retained-water regulation,
If applying “the same rigorous requirements” to poultry as to meat means requiring the poultry industry to adopt non-immersion-chilling methods, this final rule will not accomplish that objective. The food safety rationale for mandating the use of a particular technology has not been demonstrated.
FSIS has taken no position on the safety or quality of air-chilled product but has limited data on the effectiveness of air chilling, especially in large-scale operations of the kind that supply most of the poultry products sold in the United States.
The Ristic (1997) paper cited by the commenters and other studies by the same author have consistently shown air-spray chilling to have certain advantages over other methods. The studies do not compare the feasibility of air-spray chilling with that of other chilling technologies in an industry with a production volume as high as that in the United States, nor do they provide a basis for regulatory action with respect to one or another technology.
Gill, C.O., and T. Jones, 1992. Assessment of the hygienic efficiencies of two commercial processes for cooling pig carcasses. Food Microbiology 9(4):335–343.
Gill, C.O., and J. Bryant, 1997. Assessment of the hygienic performances of two beef carcass cooling processes from product temperature history data or enumeration of bacteria on carcass surfaces, 1997. Food Microbiology 14(6):593–602.
Gill, C.O., and T. Jones, 1997. Assessment of the hygienic performance of an air-cooling process for lamb carcasses and a spray-cooling process for pig carcasses. International Journal of Food Microbiology, 38(
Grier, G.G., and B.D. Dills, 1988. Bacteriology and retail case life of spray-chilled pork. Canadian Institute of Food Science and Technology journal 21:295–299.
Hamby, P.L., J.W. Savell, G.R. Acuff, C. Vanderzant, and H.R. Cross, 1987. Spray-chilling and carcass decontamination systems using lactic and acetic acid. Meat Science 21:1–14.
Jericho, K.W.F., G. O'Laney, and G.C. Kozub, 1998. Verification of the hygienic adequacy of beef carcass cooling processes by microbiological culture and the temperature-function integration technique. Journal of Food Protection 61(10):1347–1351.
Stevenson, K.E., R.A. Merkel, and H.C. Lee, 1978. Effects of chilling rate, carcass fatness, and chlorine spray on microbiological quality and case-life of beef. Journal of Food Science 43:849–852.
Ready-to-cook poultry in Europe is dryer than ready-to-cook poultry in the United States. Whether United States consumers will eventually demand poultry that is similar to the European product is a question that can be answered by the market.
FSIS does not agree with the statement that water should be considered an ingredient in immersion-chilled poultry products. Water is not added to the products being chilled to create new products.
Consumer groups commented that FSIS's own figures show consumers pay almost $1 billion/year for retained water in poultry. They said FSIS should be proposing zero retained water, and that neither meat nor poultry products should be allowed to gain water. The proposal falls well short of what is needed, they said, strongly preferring Option 2 (zero retained water) in the regulatory analysis to Option 6 (retained water limits established by processes necessary to meet food safety requirements—the selected option). They said FSIS should reconsider Options 2 and 4 (retained water limits based on best available technology within traditional production practices).
The proposal did not specify any acceptable amount of retained water, only that any amount that is retained be no greater than the unavoidable amount resulting from post-evisceration processing to achieve regulatory food safety requirements.
In the PRIA, FSIS suggested that the value of poultry production could be viewed as the production of poultry and the production of water. The Agency also said that another view was that the water has no effect on the price of poultry meat, but that the consumer is simply not being informed of the wholesale-price of poultry or turkey on a zero-added-water basis. The Agency's concern in much of the PRIA was the effect of full disclosure of retained water on consumer purchasing. The Agency concluded that this effect was unclear, though beneficial. The Agency did not take the position that water is literally being sold at poultry prices.
In the FRIA, the Agency has not attempted to quantify the overall benefits of the rule. However, FSIS rejected Option 2 and Option 4 because the costs to industry would be substantially disproportionate to consumer benefits.
This rule will ensure that water retention is limited to the amount unavoidable for food safety reasons, and that consumers are informed about this water retention. In establishing zero water retention as the default requirement, the rule compels the industry to justify scientifically any amount of water retention in raw, single-ingredient, meat or poultry product. Water in excess of the amount that is scientifically justified will adulterate the product.
The commenter stated that irradiation at doses lower than those resulting in off-odors yields spore formers like
As for antimicrobial interventions used with immersion chillers, chlorination of chiller water is not entirely effective and forms toxic organochlorine compounds that have environmental impacts. Phosphates used in post-chill dips facilitate water retention.
Eliminating retained water in poultry would “correct a consumer fraud and [an] advantage poultry has over other parts of the food industry.” The result of imposing regulatory limits on water retention after continuous chillers were introduced was to allow the poultry industry to sell “legally adulterated product.”
Regarding chlorination, FSIS agrees that organochloride compounds form in chlorinated poultry chill water. Nevertheless, FSIS considers the potential food safety benefits of chlorination to outweigh the risks.
The adulteration hazard of phosphates (extra water pick-up) that are used on raw products is exaggerated for two reasons. First, some phosphate compounds, such as orthophosphate dips, have been approved for use on raw products but are not in general use. Second, the treatment of raw products with such anti-microbial phosphate solutions as TSP should not be equated
On the charge that regulatory water retention limits constitute legalized adulteration and a fraud, the Agency points out that the water retention that it is allowing would have to be disclosed on the label. Therefore, there would be no fraud. The Agency also believes that in appropriate circumstances, it could determine that some water retention is necessary, is unavoidable, and would not need to be disclosed. However, those circumstances have not been established in this rulemaking.
Regarding protocol review procedures, as discussed below, in response to comments, the Agency has decided not to pre-approve the data collection protocols establishments will use because to do so would contradict its regulatory policy which is opposed to command-and-control regulation.
The establishment might consider plotting available
FSIS is not prescribing any particular method for establishments to use to determine the amount of retained water in their products. A number of chemical and physical methods are available for determining the amount of moisture in foods, such as the method described in Appendix A of this document.
Simply imposing a regulation that limited water retention would not inform consumers of the retained water content of products unless specific water retention limits were clearly presented in the regulation. For reasons discussed elsewhere in this document, FSIS has found that it is not in a position to impose such a regulation. On the other hand, simply requiring labeling would not be consistent with the adulteration provisions of the FMIA and PPIA. Unlimited retained water would constitute economic adulteration even if identified through labeling.
If an outcome of this rule were that no raw, single-ingredient meat or poultry product retained any water from processing, a labeling requirement might eventually be unnecessary.
FSIS also does not agree that nutrition labeling can be used. First, assuming that retained water could be regarded as part of the product, and that the nutrition labeling were accurate, few consumers would notice changes in the percentages of protein, fat, or other nutrients resulting from a change in the percentage of retained water in the product. Also, a retained water statement in a nutrition facts panel would not be as conspicuous as one on the principal display panel. Moreover, because nutrition labeling of single-ingredient products is still voluntary, relatively few consumers of such products would have the advantage of even the limited amount of information on water retention that nutrition labels could convey.
However, unlike the nutrition labeling regulations, this final rule is intended to provide information directly both to household consumers and to large purchasers of meat and poultry products. Product shipped in bulk should be labeled accurately to ensure accurate formulation of further-processed products. Also, product shipped to institutions and food-service operations should be labeled with the same accuracy as product shipped to household consumers.
On the matter of exported product, the industry does not produce, and FSIS does not regulate, a separate class of raw, single-ingredient, meat or poultry product for export to which this rule would not appropriately be applicable. Thus, FSIS disagrees that export product should be subject to retained-water labeling requirements different from those to which product for domestic sale is subject.
This 1-year pre-implementation period will enable FSIS to prepare sampling, testing, and document review procedures; train Agency personnel in the new procedures; and develop a new national reference database on the natural moisture content of raw products in the various meat and poultry product classes. However, establishments can voluntarily implement the provisions of this rule in advance of the effective date.
It is true that a consumer may not be able to compute the exact percentage of retained water in a product labeled “with up to X% retained water.” The establishment that prepared the product, however, will have had to determine a water-retention range based on the data used to determine the amount of retained water that is unavoidable in the product. The establishment will be free to label its product with the water-retention amount that reliably represents the amount that is in the packaged product.
Consumers of the product will have available more information on water retention than they have had in the past.
The commenter did not say whether the 2-percent moisture loss was additional to or part of the 4-percent retained-water amount represented on the label. FSIS assumes that the 2-percent loss is from the 4-percent amount. Thus, in the example presented by the commenter, the retained-water statement should reflect that the product contains at least 2 percent or as much as 4 percent water from processing.
Using the 3-pound dry-tare chicken example presented in the PRIA and FRIA, the product net weight in a wet-tare jurisdiction would be as much as 2.94 lb. or as little as 2.88 lb. The labeled net weight corresponding to a “2-percent” retained-water statement would be 2.94 lb. The loss to the product, labeled with this net weight, of an additional 2 percent in water weight would raise the issue of short weighting. The actual net weight of the package would enter the “gray area” provided in the NIST Handbook 133 procedures for determining net-weight compliance in wet-tare jurisdictions. FSIS and local weights and measures authorities would then follow the procedures provided for gray-area product. Depending on the wording of the retained-water statement, this loss of additional moisture could mean that the statement is inaccurate, and the product misbranded for that reason.
If a company has had difficulty in determining the unavoidable amount of retained water in the product, the company should recheck the data on which its determination of “unavoidable” is based, its data-collection protocol, and its processing procedures.
If the company knows that the product will lose 2 percent of net weight because of water loss while in distribution channels, the company should adjust the retained-water statement to account for the fact. If the company knows that a retained-water product will continue to retain a certain percentage when it is sold in the wet-tare jurisdiction, the retained water statement must account for that percentage of water retention.
The currently available data on water retention provide an inadequate basis for setting any retained-water standard because the data that could be applied to the industry are based on industry practices that conformed to the regulations that the U.S. District Court set aside in
FSIS would have to have new data, collected under new protocols and criteria that meet the concerns expressed in the Court decision in
FSIS agrees with the commenter who cited the analysis in the PRIA of available water retention data. This analysis indicates that water retention can be held at substantially below the regulatory limits that were set aside by the United States District Court in
Under this final rule, though, FSIS will be verifying compliance with the retained-water limitation and labeling requirements primarily by reviewing establishment water-retention data collected under the required data-collection protocol. The Agency also plans to conduct in-plant and in-distribution tests of the moisture content of products using the oven-drying method described in the Agency's Chemistry Laboratory Guidebook and in Appendix A of this document. FSIS will not be dictating to industry the in-plant sites for measuring and controlling retained water.
Establishments must be aware that the Agency will be most concerned with the amount of retained water in product that has entered commerce.
Also, the decision in the
Regarding the labeling requirement in the final rule, it will prevent misbranding of products subject to the rule.
With respect to the labeling issue, FSIS thinks that the
Therefore, FSIS is requiring that meat and poultry products be labeled to show the maximum amount of water they may retain. In the absence of data, the Agency is taking the most logical and reasonable course of action available to it.
Regarding the U.S. District Court decision in the
However, the Court found that the Secretary acted arbitrarily and capriciously in not adequately explaining the reasons for the water retention limits for poultry products and in not explaining why water retention could not be further reduced. In other words, the Secretary did not provide a basis for determining whether and what amount of water retention should be permitted or could be considered non-adulterative, or what amount of water retention is unavoidable in a poultry product. Put another way, the Secretary did not provide a basis for distinguishing a poultry product with permissible retained water from such a product adulterated by excessive retained water. The Court also found the Secretary to have acted arbitrarily and capriciously in not according the same regulatory treatment to meat and to poultry. The Court therefore set aside the regulation that provided the water retention limits for poultry products (9 CFR 381.66(d)(2)).
Thus, this situation is distinguishable from that in
FSIS is not stating in this final rule what the justification for retained water should be beyond stating that it must be an unavoidable consequence of processing to meet food safety requirements. This is the only justification FSIS can find for the presence of retained water in a livestock or poultry carcass.
As stated previously in this document, the Agency has consistently required that establishments minimize retained water in meat and poultry
In order to determine whether or not a poultry product is economically adulterated by retained water, the Agency must have available to it data that show what the amount of unavoidable retained water is and the amount that the product retains. Hence, the requirement that establishments collect such data according to written protocols.
FSIS is trying to minimize the cost impacts of the labeling requirements of this final rule by providing ample time for implementation and allowing the industry to use existing stocks of labels until they are exhausted. FSIS also is providing a degree of flexibility by permitting establishments to place the required retained water statement either contiguous to the product name or elsewhere on the principal display panel of the label.
FSIS is removing the second sentence of the paragraph, which prohibits the chilling in water and ice of individual parts from salvage operations. While the purpose of this prohibition, to prevent the marketing of parts that retain too much water, coincides with some of the objectives of this final rule, it is a command-and-control requirement that is inconsistent both with HACCP and with the basic thrust of this final rule. FSIS published the retained-water proposal in the same issue of the
This final rule, however, applies to transversely split carcasses and other portions and parts of poultry. It applies to all raw, single-ingredient, poultry products. This final rule makes redundant the requirements concerning the specific chilling method applied to these parts or portions of poultry. Therefore, the Agency is removing these requirements.
FSIS finds that the proposed 9 CFR 381.66(d)(2), requiring the establishment to supply measuring devices or scales for use in measuring retained water, should be retained to ensure that both the establishment and the Agency can conduct in-plant checks for compliance with this final rule.
Under § 441.10(a), raw livestock and poultry carcasses and parts may not retain any amount of water resulting from post-evisceration processing, absent a demonstration, with data, by the establishment preparing them that such water is the unavoidable consequence of a process used to meet applicable food safety requirements. The data must have been collected according to a written protocol.
Under § 441.10(c)(1), the establishment must keep this protocol on file and available to FSIS personnel. The protocol must explain how the data will be collected and used in making the required demonstration for the product the protocol covers. Under § 441.10(c)(2), the establishment must notify FSIS as soon as its data-collection protocol—whether new or revised—is available to the Agency. Within 30 days after receipt of this notification, FSIS may object to or require the establishment to make specified changes in the protocol. FSIS will take this action if it determines that the protocol is not valid, or that the data collected under it will not be sufficient to demonstrate that the amount of water retained in the product is an unavoidable consequence of the process used to meet applicable food safety requirements.
FSIS is including in § 441.10(d) the expected elements of a protocol for gathering water retention data. These protocol elements were published for comment as Appendix A of the September 11, 1998, proposal.
Under § 441.10(b), meat or poultry products will have to bear a label statement of the maximum percentage of water absorbed and retained as a result of post-evisceration processes. A qualifying statement accompanying the product name could read, “may contain up to __ percent absorbed water.” The percentage must reflect the maximum percentage of water that may be retained in the product. Alternatively, the label may simply bear an accurate statement of the percentage of retained water in the product. Establishments having data or information to demonstrate that their products do not contain retained water will not have to label the products and could include a no retained water claim on the product label. The labels will be generically approved pursuant to 9 CFR 317.5(b)(2) or 381.133(b)(2).
This requirement, which is responsive, in part, to the AMI petition discussed above, would ensure that accurate information concerning the product is conveyed to the consumer in accordance with the misbranding provisions of the FMIA and the PPIA (especially 21 U.S.C. 601(n)(1), (6); 453(h)(1), (6)). It will ensure that the product labeling is not misleading with respect to water retained by the product.
FSIS had proposed that the retained-water statement be contiguous to the product name on the product label. In response to comments, the Agency is providing some flexibility in this matter by also permitting the statement to appear either contiguous to the product name or elsewhere on the principal display panel of the label. The placement of the required information on the label will ensure that the information will be likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
With the required labeling information, consumers will be in a better position to compare packaged raw meat or poultry products containing retained water with alternatives in the meat case. The market will provide incentives to plants to adopt new, cost-effective technologies for reducing retained water. The rule will not affect raw products that now bear complete labeling or nutrition labeling, such as pre-basted frozen turkeys, or further processed products, such as deli meats. This final rule also will not cover cooked and cured pork products, such as those subject to protein-fat-free requirements (9 CFR 318.19(a)(5), 319.104–.105, 327.23).
As stated elsewhere in this document, the Agency's concern in this rule is to ensure that products in commerce will not be adulterated or misbranded. To alleviate some confusion on this point that was expressed in a number of the comments received, the labeling provision in new § 441.10(b) has been more precisely phrased than in the proposal.
FSIS is amending the chilling requirements for poultry by removing various prescriptive requirements and specifications, such as the minimum amount of fresh water intake by continuous chillers for each poultry carcass. The removal of those requirements should encourage processors to use the most efficient and effective methods of controlling microorganisms. Establishments will have the flexibility to take advantage of the latest technologies and procedures.
This final rule amends 9 CFR 381.65, which concerns general operating procedures, by removing provisions that are redundant, excessively detailed, or inconsistent with the PR/HACCP final rule. The final rule eliminates current paragraph (b), the prohibition on handling and storing materials that could cause adulteration of poultry products in any room where poultry products are processed, handled, or stored. This provision is unnecessary because HACCP plans have been implemented in every affected establishment and because each HACCP plan must specify the measures to be taken to protect poultry products from physical, chemical, or biological contamination. The requirements in paragraphs (a) and (c) of 9 CFR 381.65 will be retained as paragraph (a) and (b) because they set out general principles of sanitation and commercial practice to which all establishments must adhere.
The requirements in paragraphs (h) and (j) of 9 CFR 381.65, relating to poultry thawing and dressing techniques, are being replaced with two performance standards. The first requires simply that establishments use thawing procedures that will prevent adulteration of, or net weight gain by, the product. The second requires that water used in washing ready-to-cook poultry be permitted to drain freely from the carcass. A new paragraph (c), which replaces paragraph (h), requires that frozen poultry be thawed for further processing in a manner that will prevent product adulteration but would not require that any specific thawing method be used.
The thawing regulation that is being replaced does not prevent practices that may constitute hazards to food safety. For example, it does not prevent re-exposure of thawed, or partially thawed, product to a thawing medium that may have become contaminated by previous use and that may be too warm to prevent microbial growth. Paragraph (h)(1)(i) specifies a maximum permitted thawing medium temperature of 70 °F, which is too high to prevent microbial growth in product that is re-exposed to or held in the medium. The regulation conflicts with HACCP because establishments should assess thawing processes when conducting their hazard analyses. Establishments must be given the responsibility and flexibility to choose thawing measures that are effective and that do not create food safety hazards.
A new paragraph (d) replaces paragraph (j), which specifies the manner in which carcass wash water is to be drained, with a performance standard requiring simply that the wash water be permitted to drain freely from the carcass.
Paragraph (d), which contains a requirement to remove kidneys from
Paragraph (i), which specifies how poultry carcasses are to be cut open for evisceration, is being removed. The regulation is outdated and prescriptive and may be an obstacle to improved product safety. The regulation is intended to ensure that opening cuts are made without cutting the intestinal tract and without contaminating the carcass. Unnecessary cuts are prohibited because they may result in carcass contamination during evisceration or excessive water absorption during chilling. The regulation is also intended to maximize the viewing of the interior and viscera of the carcass during the postmortem inspection.
In recent years, the poultry industry has developed new methods of poultry evisceration that do not result in adulteration. For example, ultrasound techniques are available for use as a diagnostic aid to detect malformities or other defects before carcasses are opened. Also, equipment is available that can remove the viscera intact, using vacuum suction, without breakage or spillage of intestinal contents, and other available evisceration systems require that the carcass be opened by a longitudinal cut. The regulation generally limits the opening cut to the area around the vent (cloaca) to prevent birds from carrying excess water under the skin that could cause water-control test failures. Because of this limitation, the new technologies, which can improve efficiency and product wholesomeness, are not likely to be implemented. Establishments, however, should have the flexibility to innovate and to implement promising new technologies, consistent with their HACCP plans.
Paragraph (k), a requirement to adequately drain ready-to-cook poultry after chilling to remove ice and water before packaging, is redundant because of new part 441, and FSIS is removing it.
Paragraphs (l) through (p) are also being removed. These paragraphs include requirements concerning the chilling of poultry parts, the removal from establishments of offal resulting from evisceration, the cleanliness of containers, the sturdiness of packaging materials, and the use of protective coverings. These are all matters that are to be addressed by establishments in their Sanitation SOP's and HACCP plan.
Finally, paragraph (q), concerning the harvesting of detached ova for human food, is being re-designated as paragraph (e) and revised to reduce duplication with requirements in § 590.440 for handling ova and to eliminate a command-and-control requirement to identify the ova past the point of inspection. Also, the reference to a section of the egg products inspection regulations has been amended to account for the recent redesignation (63 FR 72353) of those regulations to Title 9, CFR.
In 9 CFR 381.66, paragraph (a) is being revised. This paragraph requires poultry to be chilled or frozen in a manner that promptly removes animal heat from the carcasses and does not adulterate the product. The second sentence of the paragraph, a command-and-control requirement to file a description of the chilling or freezing procedures with the inspector in charge, is being removed.
The general chilling requirements for poultry, paragraph (b), remain the same. FSIS has long regarded the chilling of poultry to a safe internal temperature within a minimum number of hours as a useful food safety precaution. However, as mentioned above, the Agency intends to undertake rulemaking on this matter. The table of maximum times and temperatures in paragraph (b) is based on the duration of the lag phase of bacterial growth on the surfaces of dressed, ready-to-cook poultry carcasses under plant conditions. Although interested persons are encouraged to submit data that would justify a change in this provision, amending the paragraph is outside the scope of the present rulemaking.
The numerous detailed, prescriptive, command-and-control requirements in paragraph (c) are being removed. For example, the amended paragraph (c)(2)(i) does not specify chilling media temperatures or the use of recording thermometers. New paragraph (c)(1) requires that potable water be used, and new paragraph (c)(2)(i) requires that sufficient water be used to maintain the sanitation of chilling media. However, specific requirements (paragraphs (c)(2)(ii)–(iii) and (c)(2)(v)) concerning the operation of continuous chilling systems, including the minimum amount of fresh water intake per bird, are being removed.
Paragraph (c)(2)(iv) is being re-designated as (c)(2)(ii) and revised as discussed above in the response to comments. This paragraph, which concerns the chilling of major portions of poultry carcasses, was the subject of a September 18, 1999, final rule (63 FR 48958; proposed at 62 FR 31017; June 6, 1997).
Paragraph (c)(2)(vi), the highly detailed and prescriptive requirements concerning water-reconditioning systems for poultry chillers, including the requirement for prior approval of such systems by FSIS, is being removed. Establishments subject to the poultry product inspection regulations are not using these systems because none have proven feasible in commercial operations.
The requirements in paragraphs (c)(4)(i) and (c)(4)(ii), concerning the holding of poultry in chilling tanks, are being removed, and in paragraph (c)(5), the highly specific requirements concerning the use of continuous chillers to chill giblets are also being removed. Establishments will address the food safety hazards associated with these procedures in their HACCP plans. However, the requirement to chill giblets to less than 40 °F in under 2 hours will remain at this time.
Paragraph (d) of § 381.66 is being completely revised. The general requirement to minimize water absorption by raw poultry, and the requirement to furnish equipment necessary for water tests, will remain. The tables setting water absorption and retention limits for the various kinds and weight classes of poultry are being eliminated, as are the requirements for daily water testing by FSIS inspectors. The requirement to notify FSIS of any adjustments in washing, chilling, and draining methods is also being removed.
FSIS is removing paragraph (d)(10), which specifies how poultry may be ice-packed in barrels and requires FSIS approval for the use of alternative types of containers. Establishments will ordinarily have procedures for determining appropriate containers for a product. If, in their hazard analyses, they determine that there are food safety hazards reasonably likely to occur that are associated with containers, they will address these hazards in their HACCP plans.
The Agency is likewise removing paragraph (d)(11), which requires establishments to prevent free water from being included in giblet packages. Among other things, paragraph (d)(11) requires use of a specific type of giblet wrapping material and incorporates by
Finally, paragraph (e), on air chilling, and paragraph (f), governing the freezing of poultry, are being retained substantially in their present form. Paragraph (f)(6), concerning immersion or spray freezing compounds and equipment, will be removed because it is a prior-approval requirement inconsistent with the HACCP regulations and is duplicative of other inspection regulations.
FSIS foresees little difficulty in implementing the revised poultry chilling regulations, which relieve poultry establishments of certain burdens without raising misbranding or adulteration issues. FSIS will ensure compliance with the revised regulations through normal inspection.
To implement the retained-water provisions of this final rule, on the other hand, both the Agency and the regulated industry will have to adopt new procedures. FSIS personnel will verify an establishment's control of water retention by checking establishment records or by conducting in-plant or in-distribution tests of sampled products. FSIS intends to sample product in distribution channels and in official establishments, using the oven-drying method described in Appendix A to determine the amount of moisture in product samples. At poultry processing establishments, the traditional method of weighing birds before and after chilling to determine moisture pick-up will continue to be available to both the Agency and the establishments as a process control check.
FSIS also will conduct independent tests of the establishment's retained-water control as part of investigations of suspected problems or in the course of special studies. The overall focus of the Agency's activities will be to ensure that raw products that enter commerce do not contain water in excess of the amount that is unavoidable in achieving food safety objectives.
FSIS is providing a full year from the publication date for implementation of this final rule to mitigate the effects of the rule on establishments that may have to consider changing or updating their chilling processes and equipment. The extended implementation period should be especially helpful to establishments that meet the small-business-entity size criteria defined by the Small Business Administration.
During the period before the effective date, FSIS will provide its field inspection personnel with the instructions they will need to carry out their review of protocols and verify that establishment data demonstrate the amount of water retention that is unavoidable and support product labeling statements. The Agency will prepare sampling, testing, and document review procedures for Agency use; train Agency personnel in the new procedures; and develop a new national reference database on the natural moisture content of raw products in the various meat and poultry product classes with which this rule is concerned.
To develop this national database on natural moisture content, FSIS will test product samples drawn at official establishments. The Agency will use a common, analogous point of reference in livestock carcass and poultry product preparation at which to determine the naturally occurring percentage of moisture in meat products and poultry products, namely, the point at which the calculated yield weight is determined. (Calculated yield weight of a carcass is its predicted “green weight”—the weight of the carcass after dressing and before any additional in-plant processing.) In poultry plants, this point is at the re-hanging operation (after de-feathering and hock removal). The analogous point in livestock slaughtering establishments is before the pre-evisceration carcass wash. FSIS has chosen these common reference points to reduce the possibility of measurement errors caused by various carcass-washing procedures.
To determine the moisture content of a product sample, the Agency plans to rely on the oven-drying method described in its Chemistry Laboratory Guidebook and in Appendix A of this document. This method involves weighing, before and after drying, a dish containing a homogenized meat or poultry product sample. The method can be applied to products at any point in processing or distribution. Similar oven-drying methods for determining the amount of moisture in meat, meat products, and poultry products are described in the Official Analytical Methods of the Association of Official Analytical Chemists and in ISO 1442, published by the International Organization for Standardization.
After developing sufficient information on the natural water content of raw meat or poultry products, FSIS will be in a better position to verify that the establishment is complying with the requirement to minimize retained-water amounts when the final rule becomes effective. To determine whether an establishment is complying with the regulations, the Agency will verify the establishment's protocol documentation and the data collected under the protocol, including data on retained-water minimization and pathogen reduction. FSIS also will verify compliance with the requirement that product labels display retained-water amounts, and that the actual retained water in the products corresponds to the labeled amount.
Usually, the verification will consist only of a document check. However, the Agency will occasionally test products for moisture content to verify the establishment's findings.
FSIS will randomly sample raw meat and poultry products both in-plant and in-distribution and will test the products for retained water content. FSIS will collect and run tests on product samples and statistically analyze the results of the tests.
The Agency will directly measure the moisture content of the raw products sampled in-plant at pre-shipment using its oven-drying method. The Agency will compare the results of these tests with the naturally occurring amounts of water in the national reference database and with the retained-water statements on the product labels to determine whether the products are in compliance with the requirement to minimize retained water, and whether they are correctly labeled with a retained-water statement.
To measure the amount of retained water and determine compliance with the final rule in in-plant situations when using the weighing method, FSIS will compare product weights taken after chilling, but before the product leaves the establishment, to the pre-final-wash weight or (in poultry plants) the calculated yield weight. In livestock slaughtering plants, the Agency expects to be comparing pre-final wash or “hot” carcass weights with the “cold weights” taken after spray chilling in establishments using the spray-chill process.
The Agency does not expect to use calculated yield weight data as a basis for comparing hot and cold livestock carcass weights because such data are not available for most livestock establishments. The great majority of such establishments do not weigh carcasses after de-hiding or de-hairing and before the pre-evisceration wash. FSIS is aware that there may be a slight, measurable gain in carcass weight immediately after the pre-evisceration wash. However, this gain is usually more than offset by moisture loss on the kill floor. Thus, the “hot” carcass weight does not include a moisture gain resulting from the pre-evisceration wash.
FSIS is not prescribing any particular method that official establishments must use to measure the amount of retained water in their products. Establishments are free to use any scientifically valid method for this purpose. Establishments may want to use the food chemistry method described in Appendix A and used by FSIS to determine the moisture content of their products. Because of the destructive nature of the method and the delay in getting results, establishments may find it more convenient on a day-to-day basis to compare the weights of carcasses and parts before and after they are exposed to washes, sprays, or immersion chilling. The data from such checks would have to be available to FSIS to verify. As mentioned, poultry establishments will continue to be able to use the traditional method involving the weighing of birds before and after chilling as a check on water retention controls.
FSIS also will conduct surveys of products in plants and in distribution channels to obtain an overview of national compliance with the regulations and to update the national reference database on the moisture content of meat and poultry products. The Agency will compare the results of these surveys with the information in its database to determine whether any adjustments in its enforcement of the regulations are necessary. Comments are requested on sampling and survey methods that the Agency should consider using both for initially building the national reference database and for the on-going compliance overview.
FSIS will continue to verify that products are in compliance with the net-weight requirements for meat and poultry products. As stated elsewhere in this document, neither the net-weight requirements nor the obligation of an establishment to comply with them is affected by this final rule.
FSIS expects there to be requests for adding water solutions to meat and poultry manufacturing trimmings in an effort to reduce the pathogen levels on product. Such applications may or may not result in retained water, as well as chemical residues. FSIS expects such applications to adhere to the same criteria as other applications resulting in retained water. FSIS will allow establishments to implement the provisions of this final rule in advance of the effective date provided the establishment informs the appropriate District Office in order that inspection program personnel are provided with the necessary instructional materials. FSIS expects to provide instructions regarding early implementation of the final rule.
The regulations controlling retained water in poultry carcasses have consisted of three major components: (1) A performance standard requiring washing, chilling, and draining practices that will minimize water absorption and retention at time of packaging; (2) limits for maximum retained water in birds that will be packaged as whole carcasses; and (3) limits for maximum retained water in birds that will be ice-packed or cut up prior to packaging. The performance standard is to minimize the water that is absorbed and subsequently retained,
Until the
As discussed previously, FSIS is mandated by the FMIA and PPIA to prevent the distribution in commerce of meat or poultry products that are adulterated or misbranded. Without limits on retained water, FSIS cannot adequately protect consumers from adulteration and misbranding due to excessive retained water in whole birds. Hence, the Agency is establishing a new regulatory basis for minimizing retained water.
FSIS is replacing the regulations under which poultry establishment was considered to be “minimizing” retained water when it was operating within the regulatory limits. FSIS is aware that not all establishments have really been minimizing retained water. Data analyzed for this FRIA show that some poultry establishments have been controlling their processes to retain the maximum allowed amount of water. While this is considered acceptable in the sense that product is not adulterated, it is not consistent with a regulatory intent to minimize. However, it may be consistent with food safety objectives to reduce pathogens.
The existence of the 12-percent limit for cut-up chicken is in itself inconsistent with the concept of minimization. Many establishments pack both whole-and cut-up chicken. In meeting the 8-percent limit for whole birds, they demonstrate that their minimum is below 8 percent. The 12 percent limit serves as an opportunity to maintain water levels in cut-up poultry. The 12-percent limit is also available as default when the 8-percent limit is not achieved. An establishment can divert birds to cut-up operations when they fail the whole bird limit.
With this final rule, FSIS also is addressing the issue of inconsistent treatment of meat and poultry in its regulations because, under the final rule, both meat and poultry products will be subject to the same requirements.
The FMIA and PPIA, which the Agency administers, make clear the
As noted earlier in this document, a 1997 U.S. District Court decision set aside the regulatory limits on retained water in poultry products. The District Court found that the Agency had not presented the basis for its retained water levels, why water retention could not be reduced below those levels, or why meat and poultry should be regulated differently with respect to water retention.
The District Court ruling left FSIS without regulatory criteria for determining whether retained water had been minimized or what levels constituted adulteration. The Agency also no longer had available published retained water limits that it could enforce in an effort to protect consumers from misbranded product.
This rule resulted from an analysis of six alternative regulatory approaches for addressing retained water in raw meat and poultry products. The six alternatives are as follows:
1. No limit on retained water but mandatory labeling that identifies the percentage of retained water in the product. FSIS did not recommend this alternative for adoption because it would not reduce retained water so that economic adulteration would continue to persist. It would, however, be advantageous to consumers because it would enable them to compare alternative packages of poultry with varying quantities of retained water and prices and select the package to suit their budgets.
2. A requirement that all establishments meet a water limit based on best available technology, with mandatory labeling to indicate any retained water. FSIS did not propose this option because the adoption of the best available technology would be a step backward into a regime of command and control. It would also impose considerable costs on plants that are currently not employing such a technology without a corresponding improvement in food safety. For example, if the best available technology is determined to be the continuous chillers, there are several small and medium size plants that do not employ this technology. The economic impact of such an option would be significant on these plants. In the current environment of regulatory reform, FSIS is moving away from command and control to incentive-based performance standards. Such standards permit plants to reduce their retained water levels irrespective of the technology they employ. A moisture limit based on the best performance achievable with existing equipment, with mandatory labeling to show any retained water. FSIS did not adopt this option because, beyond stating that water retention should be minimized consistent with maximizing the safety of the product, it would be difficult, if not impossible, for FSIS to define the best performance achievable. This option would also encourage establishments to continue to use existing equipment, perhaps beyond the economic life of the equipment.
3. A standard of zero retained moisture. FSIS did not recommend this option because the costs of this option might exceed the benefits. Finally, some minimum amount of retained water might be necessary for reducing pathogens.
4. A requirement that no retained water could be included in net weight. FSIS did not recommend this option for adoption because it would require establishments to adjust their scales to account for retained water. The costs of adjusting these scales could be excessive. Moreover, enforcement of net weight requirements is an area where Federal, State and local authorities share responsibility and must cooperate. The enforcement procedure, as adopted by the National Conference on Weights and Measures, are published in NIST Handbook 133, Third Edition, Supplement, “Checking the Net Contents of Packaged Goods”. The National Institute of Standards and Technology (NIST) has a statutory responsibility for “cooperation with the states in securing uniformity of weights and measures laws and methods of inspection.
5. A requirement of zero retained water unless the water retention is unavoidable in processes necessary to meet food safety requirements,
FSIS chose the last alternative. The selected option does not allow retained water in an affected product unless it is an unavoidable consequence of the process or processes used to meet applicable food safety requirements. By “unavoidable consequence” the Agency means an unavoidable and irreducible side effect. Under this option, inspected establishments, associations, or other groups, using acceptable protocols must establish levels of unavoidable retained water. Also, the maximum amount of retained water that can be present must be stated on the product label. FSIS has found that this option is likely to provide greater benefits than other options because it is more flexible and likely to prove less costly than some of the proposed alternatives. A food safety requirement can be a regulatory prescription, such as the temperature to which a product must be chilled and held. It can also be a preventive measure taken at a CCP or a critical limit in the establishment's HACCP plan. For example, the proposed rule might increase human handling for transferring products from the chillers to the freezer, thereby increasing cross contamination. A critical control point at such handling could reduce, if not eliminate, cross contamination. Given a food safety requirement, an establishment must choose a method for satisfying the requirement.
The method selected for meeting food safety requirements may have unintended consequences that cannot be eliminated. A consequence of an antimicrobial treatment of carcasses or a carcass chilling method may be an increase in the water content of carcasses and parts. FSIS is requiring that the amount of water that might be retained in carcasses and parts as a result of using such an anti-microbial or chilling method be an unavoidable and irreducible effect of using that method.
To be applicable to the raw products of an inspected establishment, a non-zero retained-water limit would have to be based on supporting data collected in accordance with a written protocol that has been subject to review by FSIS. This final rule will allow an individual establishment or industry trade association or other group using the same or similar processing techniques to develop a protocol and carry out data-generating studies according to the protocol. Depending on the design of the protocol, the data gathered could justify water-retention limits for a single establishment, a group of establishments with similar equipment processing similar classes of raw product, or all such establishments in an industry. To establish a non-zero retained water limit, an inspected establishment, industry trade association, or other group would have to generate the necessary supporting data. The labels of products would have to state the presence of retained water in the products.
The analysis estimates a range of costs the poultry industry will incur to meet this new regulatory requirement. If establishments are able to demonstrate that current levels of retained water are unavoidable in achieving applicable food safety standards, establishments will not incur additional costs for reducing retained water. These establishments would only incur costs for establishing limits and costs for labeling the product. The costs of
To the extent that establishments cannot demonstrate that current retained water levels are unavoidable in achieving applicable food safety standards, significant costs could be incurred as establishments modify processes to minimize retained water levels. FSIS estimates that the average retained water for chicken, as a percentage of net weight is currently in the 5.0 to 6.5 percent range. The corresponding level for turkey is 4.0 to 4.5 percent. Reducing retained water could entail a wide range of process modifications, depending on the type of chilling equipment currently used and amount of retained water that would have to be removed. FSIS estimates that, if extensive modifications to chilling systems were needed throughout the industry, the fixed costs associated with removing a substantial portion of the existing retained water could run to well over $100 million. The substantial portion was defined in the PRIA, viz., that it would take 12 hours to drain substantial portion of the retained water in chickens. The 12-hour drain would reduce the existing level range from 5–6.5 percent, by 4 to 5 percentage points,
The drip-dry process for chicken requires production workers to remove chickens from a production line, place the chickens in vats, place the vats in a cool room for 12 hours, and return the chickens to the poultry line. Besides labor, this process requires cooling space, stainless steel vats that hold up to 500 chickens, and a forklift to transfer chickens from a production line to a storage room and then back to the line after the drip-dry process is complete.
To extend draining or dripping time, many establishments would have to add refrigerated facilities, purchase vats for storing birds being drained, hire additional personnel, and purchase additional stock handling equipment. There would be inventory costs due to holding birds off the market for a longer time before shipment. Holding birds at inspected establishments would also reduce the corresponding retail shelf life.
The ERS staff developed some cost estimates for holding poultry based on the following industry input:
1. One common method of draining uses stainless steel vats at a cost of $1,000 each.
2. Vats hold approximately 500 chickens or 100 turkeys.
3. Cooler space costs $125 per square foot.
4. Vats can be stacked two high.
5. Stacked vats with aisles require 12 square feet of space per vat.
6. Forklifts to move vats cost $24,000 each.
The Daily Moisture Records sometimes include a record of the additional drain time required. The time varies with the initial water level, the drain configuration and the location of the excess water,
Most of the drain time for turkeys ranged from
To drain chickens for 12 hours is equivalent to saying the industry would need to add extra capacity to drain half a day's production, since most chicken is processed in establishments running two shifts.
Since average chicken production is 29.5 million birds per day (assuming a 260-day work year), half a day's production is 14.75 million birds. Using the above factors, this would require 29,510 vats at $29.5 million; 354.12 square feet of cooler space at $44.3 million' and $4.8 million of forklifts assuming the largest 200 chicken establishments would each require an additional forklift. In this 12-hour case, the total fixed costs would be $78.6 million ($29.5 + 44.3 + 4.8).
In addition, half a day's turkey production at 557,000 birds requiring 5,570 vats would cost $5.57 million and cooler space would cost $8.36 million. Assuming that the largest 70 turkey establishments would require an additional forklift at a cost of $1.68 million, the total fixed costs for draining all turkeys for 12 hours would be $15.61 million ($5.57 + 8.36 + 1.68).
In short, the total fixed costs for a 12-hour draining of chickens and turkeys would be $94.2 million ($$78.6 + $15.61). Since these costs were estimated in 1997, updating them with to the year 2000 would amount to about $100 million.
Variable costs of holding poultry to drain would include increased labor costs, higher utility costs, increased overheads, and the cost of carrying additional inventory. Holding half a day's production is equivalent to continually storing a wholesale value of $37 million poultry ($19.2 billion divided by 520 shifts/year). At a 5 percent interest rate, the annual cost of draining poultry for 12 hours would be $1.85 million.
It would be conservative to assume a minimum average of one additional employee per establishment. Since there are 300 establishments, the cost at $21,500 per employee per year would result in an annual labor cost of $6.4 million ($21,500 x 300). The total variable costs of $8.25 million ($1.85 + $6.4) would increase to about $10 million in the year 2000 when updated by an increase in Employment Cost Index.
To sum up, the first year costs of draining poultry would amount to $110 million ($100 m + $10 m). These are the costs of reducing retained water in the range of 1–1
However, if extensive modifications were not needed, the industry would only incur the costs of establishing retained water limits and meeting the labeling requirements of the final rule.
Because of longstanding industry petitions and the decision in the
The final rule will provide the meat industry with additional flexibility for meeting the pathogen reduction performance standards. Meat processors will be able to use pathogen reduction techniques without having to be
This final rule also will provide affected establishments with increased flexibility to choose the most appropriate means for implementing HACCP plans for protecting the safety or raw product while minimizing the potential for economic adulteration. By removing certain command-and-control requirements and providing increased flexibility for HACCP implementation, this final rule may reduce the costs of HACCP implementation.
As discussed in the preamble, this final rule eliminates many requirements, including the following:
1. The requirement that poultry establishments provide FSIS with a description of all chilling and freezing procedures.
2. The requirement that poultry establishments notify FSIS before any changes in chilling procedures are implemented and provide FSIS with test results demonstrating the effectiveness of the changes.
3. The requirements that meat carcasses cannot show any weight gain resulting from the use of carcass spray systems.
4. Elimination of minimum water intake requirements for immersion chillers.
Finally, the rule will also provide all affected establishments with the flexibility and market incentives to implement new procedures for meeting pathogen reduction performance standards. In addition, by replacing command-and-control requirements with HACCP-consistent performance standards, the final rule will eliminate some recordkeeping and reporting burdens, provide for increased flexibility, and reduce the costs of HACCP implementation.
The final rule should not have a significant impact on a large number of small businesses. Almost half of all federally inspected poultry slaughter establishments are large business entities, based on the Small Business Administration size criterion of more than 500 employees.
These establishments, and indeed most poultry establishments, use immersion chilling to meet the existing chilling requirements for poultry,
Fifty to 60 poultry slaughter establishments process under a million birds annually. Many of these smaller operations do not use continuous immersion chillers. They use ice or slush to meet the existing chilling requirements. Few, if any, would have to reduce the current level of retained water. The establishments most affected by this final rule are the firms operating immersion chillers in a manner that targets the maximum allowable retained water.
This final rule should not have a significant impact on the meat industry because that industry is already achieving zero-percent retained water. This final rule, however, provides an alternative for establishments that are having or will have trouble meeting the
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. States and local jurisdictions are preempted by the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) from imposing any marking or packaging requirements on federally inspected meat and meat products or poultry products that are in addition to, or different than, those imposed under the FMIA and PPIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat and poultry products that are outside official establishments for the purpose of preventing the distribution of meat or poultry products that are misbranded or adulterated under the FMIA or PPIA. States and local jurisdictions also may exercise concurrent jurisdiction, for the same purpose, over imported meat and poultry products that are not at an official establishment after the entry of such imported articles into the United States.
This final rule is not intended to have retroactive effect.
There are no applicable administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this final rule. However, the administrative procedures specified in 9 CFR 306.5 and 381.35 must be exhausted prior to any judicial challenge of the application of the provisions of this final rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or PPIA.
Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994), “Federal Actions to Address Environmental Justice in Minority and Low-Income Populations,” FSIS has considered potential impacts of this final rule on environmental and health conditions in low-income and minority communities.
This final rule will provide new, uniform regulations limiting the amount of water retained by raw, single-ingredient, meat and poultry products as a result of post-evisceration processing, such as carcass chilling, considered necessary to minimize pathogen growth on the products. As explained in the economic impact analysis, the regulations should generally benefit consumers of meat, meat products, and poultry products. The regulations will not require or compel meat or poultry establishments to relocate or alter their operations in ways that could adversely affect the public health or environment in low-income and minority communities. Further, this final rule will not exclude
FSIS estimates that as many as 4 percent of meat and poultry establishments under Federal and State inspection are owned by women or members of non-white minority groups. Therefore, of the establishments affected by this rule, as many as 4 percent of the establishments may be under female or minority ownership. FSIS has no reason for supposing, however, that the effects of this rule, whether adverse or beneficial, on such establishments would be disproportionate.
Public awareness of all stages of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this final rule, FSIS will announce it and provide copies of this
This final rule will require an estimated 210,000 hours to develop the data to support retained water levels above zero. All 300 federally inspected poultry establishments will need to conduct studies to establish minimum retained water levels. The FRIA assumed that the average establishment would conduct studies for two product categories. The FRIA assumed that a reasonable study would examine 10 alternative chiller settings with four 50-bird water tests conducted for each setting. Each test would require 2.5 hours. Thus, it would take an estimated 200 hours for each of 300 poultry establishments, or more than 30,000 hours.
The FRIA assumed that at most 500 meat establishments need to develop non-zero water levels to meet the existing pathogen-reduction performance standards. With larger carcasses, the recording time is doubled to 200 hours per establishment. These 500 meat establishments would also require 100 hours to collect microbial samples. Thus, the information collection would be 300 hours for each of 500 establishments, or 150,000 hours.
All 800 establishments with non-zero levels would also have to develop new, generically approved labels.
Copies of this information collection assessment can be obtained from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection Service, USDA, 112 Annex, 300 12th SW., Washington DC 20250.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Specifically, FSIS is interested in comments regarding the label requirements. Some commenters expressed concern about the usefulness, or “practical utility,” of the information on the maximum percentage of retained water that must be disclosed on the label. FSIS welcomes any information and data to support this requirement or that presents alternatives. FSIS will fully address any comments in its information collection request that it will submit to the Office of Management Budget 60 days after publication of this rule.
Comments may be sent to Lee Puricelli, see address above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington DC 20253.
Comments are requested by March 12, 2001. To be most effective, comments should be sent to OMB within 30 days of the publication date.
Food labeling, Poultry and poultry products.
Consumer protection standards, Meat and meat products, Poultry products.
7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451–470; 7 CFR 2.18, 2.53.
(b) * * *
(44)
(a) Operations and procedures involving the processing, other handling, or storing of any poultry product must be strictly in accord with clean and sanitary practices and must be conducted in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry products that are not adulterated.
(b) Poultry must be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Blood from the killing operation must be confined to a relatively small area.
(c) When thawing frozen ready-to-cook poultry in water, the establishment must use methods that prevent adulteration of, or net weight gain by, the poultry.
(d) The water used in washing the poultry must be permitted to drain freely from the body cavity.
(e) Detached ova may be collected for human food and handled only in accordance with 9 CFR 590.440 and may leave the establishment only to be moved to an official egg product processing plant for processing. Ova from condemned carcasses must be condemned and treated as required in § 381.95.
(a)
(c)
(2)(i) Poultry chilling equipment must be operated in a manner consistent with meeting the applicable pathogen reduction performance standards for raw poultry products as set forth in § 381.94 and the provisions of the establishment's HACCP plan.
(ii) Major portions of poultry carcasses, as defined in § 381.170(b)(22), may be chilled in water and ice.
(3) Previously chilled poultry carcasses and major portions must be maintained constantly at 40 °F or below until removed from the vats or tanks for immediate packaging. Such products may be removed from the vats or tanks prior to being cooled to 40 °F or below, for freezing or cooling in the official establishment. Such products must not be packed until after they have been chilled to 40 °F or below, except when the packaging will be followed immediately by freezing at the official establishment.
(4) Giblets must be chilled to 40 °F or below within 2 hours from the time they are removed from the inedible viscera, except that when they are cooled with the carcass, the requirements of paragraph (b)(2) of this section must apply. Any of the acceptable methods of chilling the poultry carcass may be followed in cooling giblets.
(d)
(2) The establishment must provide scales, weights, identification devices, and other supplies necessary to conduct water tests.
(f) * * *
(6) [Removed]
21 U.S.C. 451–470, 601–695; 7 U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53.
(a) Raw livestock and poultry carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses or parts is an unavoidable consequence of the process used to meet applicable food safety requirements.
(b) Raw livestock and poultry carcasses and parts that retain water from post-evisceration processing and that are sold, transported, offered for sale or transportation, or received for transportation, in commerce, must bear a statement on the label in prominent letters and contiguous to the product name or elsewhere on the principal display panel of the label stating the maximum percentage of water that may be retained (
(c)(1) An establishment subject to paragraph (a) of this section must maintain on file and available to FSIS its written data-collection protocol. The protocol must explain how data will be collected and used to demonstrate the amount of retained water in the product covered by the protocol that is an unavoidable consequence of the process used to meet specified food safety requirements.
(2) The establishment must notify FSIS as soon as it has a new or revised protocol available for review by the Agency. Within 30 days after receipt of this notification, FSIS may object to or require the establishment to make changes in the protocol.
(d) Expected elements of a protocol for gathering water retention data:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Appendix A will not be codified in Title 9 of the Code of Federal Regulations.
Theory: In this determination, a weighed sample is heated, cooled, and then re-weighed. The loss in weight is calculated as moisture content.
Apparatus:
a. Covered aluminum dish. At least 50 mm. diameter and not greater than 40 mm. deep, containing a paddle.
b. Mechanical convection oven, preferably one equipped with a booster heater.
c. Food chopper with plate openings ≤
For accurate and reliable measurement, the raw meat or poultry sample should be finely ground to a homogeneous consistency.
a. Accurately weigh sample (representing approximately 2 g. of dry material) into an aluminum dish.
i. Weigh the sample as rapidly as possible to minimize loss of moisture.
ii. The weight of the pan should include the paddle, which is used in spreading the sample across the bottom of the pan, thereby presenting a greater sample surface area, which is beneficial to moisture removal.
iii. If the sample is relatively dry when received, a small quantity of distilled water may be added to the pan only after the sample weight is obtained. This quantity of water will be helpful in spreading the sample across the bottom of the pan, and will introduce no error since it will be evaporated when the sample is oven-dried.
b. Dry, with cover removed, for 16–18 hours at 100–102 °C, or for 4 hours at 125 °C in mechanical convection oven.
Do not overload the drying oven or sample may be insufficiently dried and give low results. Drying time will start when the original temperature has been reached. Use the oven's booster heater, if the oven is so equipped, to minimize this recovery time.
If laboratory is not air-conditioned, and humidity is high, dishes should be desiccated before the initial and final weighings.
Reference: Official Methods of Analysis of the Association of Official Analytical Chemists, 16th Edition, 950.46.