The next meeting of the AC21 has been scheduled for May 29-30, 2012. The AC21 consists of members representing the biotechnology industry, the organic food industry, farming communities, the seed industry, food manufacturers, state government, consumer and community development groups, as well as academic researchers and a medical doctor. In addition, representatives from the Department of Commerce, the Department of Health and Human Services, the Department of State, the Environmental Protection Agency, the Council on Environmental Quality, and the Office of the United States Trade Representative have been invited to serve as “ ex officio ” members. The Committee meeting will be held from 8:30 a.m. to 5:00 p.m. on each day. The topics to be discussed will include: final reports from the four AC21 working groups on analyses relevant to the overall AC21 charge; potential economic impacts on farmers from the escape of certain genetically engineered crops with functional traits; and further analysis of committee members' views related to the Committee charge in order to identify areas of agreement as well as differences and to prepare for development of a draft report.

Background information regarding the work and membership of the AC21 is available on the USDA Web site at http://www.usda.gov/wps/portal/usda/usdahome?contentid=AC21Main.xml&contentidonly=true. Members of the public who wish to make oral statements should also inform Dr. Schechtman in writing or via Email at the indicated addresses at least three business days before the meeting. On May 29, 2012, if time permits, reasonable provision will be made for oral presentations of no more than five minutes each in duration.

The meeting will be open to the public, but space is limited. If you would like to attend the meetings, you must register by contacting Ms. Dianne Fowler at (202) 720-4074 or by Email at Dianne.fowler@ars.usda.gov at least 5 days prior to the meeting. Please provide your name, title, business affiliation, address, telephone, and fax number when you register. If you are a person with a disability and request reasonable accommodations to participate in this meeting, please note the request in your registration. All reasonable accommodation requests are managed on a case by case basis.

Background Public Meeting

On March 10, 2010, FSIS held a public meeting to discuss the Agency's ongoing efforts to improve product traceback related to E. coli O157:H7. 1 Noting that the July 2009 Key Findings Report of the President's Food Safety Working Group identified the ability to trace contaminants back to their source as a high priority for ensuring a safe food supply, 2 FSIS officials described the Agency's current traceback policy and discussed changes the Agency was considering to improve its traceback efforts.

Under FSIS's current traceback policy, FSIS does not begin conducting any investigations or follow up activities until positive results based on FSIS testing are identified or until outbreaks occur. Based on FSIS positive test results or other Federal or State Agency positive test results, FSIS conducts Food Safety Assessments (FSAs) at establishments that produce product (ground beef, beef manufacturing trimmings, or other raw ground beef components) that is positive for E. coli O157:H7. FSAs are complete investigations concerning the establishment's entire HACCP system. FSIS also conducts FSAs at supplier establishments that are sole source suppliers for product that FSIS or another Federal or State Agency has found positive for O157:H7, or at establishments that FSIS has found provided source materials for product that FSIS or another Federal or State Agency has found positive more than once in the last 120 days. FSIS Enforcement, Investigations, and Analysis Officers (EIAOs) conduct these FSAs and are trained specifically for these assessments. FSIS also conducts investigations in response to outbreaks, working with CDC and State or local Agencies.

The contemplated changes discussed at the March 10, 2010, public meeting focused on improving FSIS's ability to quickly trace all adulterated products that are implicated by an E. coli O157:H7 positive test of raw ground beef or bench trim (defined as, beef manufacturing trimmings derived from cattle not slaughtered on site at the establishment). For example, Agency officials explained that FSIS intends to implement new investigations of production practices at establishments that produced product FSIS finds presumptive positive for E. coli O157:H7. Similarly, based on presumptive positive results, Agency officials stated that FSIS intends to implement new investigations of production practices at the establishments' suppliers. FSIS officials explained that FSIS did not intend to wait for confirmation results before initiating these investigations because the Agency believes it is imperative to more quickly identify all affected product and all potential suppliers.

Agency officials also discussed the importance of focusing on slaughter and dressing operations—where contamination is most likely to occur—in mitigating the risk of E. coli O157:H7 contamination of raw ground beef products.

Finally, Agency officials described the role played by identifying high event periods (HEPs) in determining whether a systemic breakdown of process control at a slaughter establishment may have led to cross-contamination between multiple production lots. Agency officials explained that this type of loss of process control and cross-contamination would create insanitary conditions that may affect the disposition of intact (primal and subprimal) cuts of beef, in addition to beef manufacturing trimmings. If loss of control leads to insanitary conditions, more product may be adulterated than just the product found positive for the pathogen. In this situation, it is very important that establishments identify all product that may be adulterated and hold that product back from commerce to avoid expensive recalls. FSIS notes that recalls can result in costs of $3-5 million. 3

Agency officials also described draft compliance guidelines issued by FSIS on August 12, 2008, that included the Agency's then current thinking regarding HEPs. 4 They noted that the Agency had received and considered comments related to that draft guidance document. The transcript to the public meeting and materials presented at the public meeting is available at the following site: http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.

Public comments made during the meeting and others submitted later stated that FSIS needed to take additional actions related to traceback in instances involving sole source suppliers of E. coli O157:H7 positive product. These commenters emphasized the need to identify these sole source suppliers in order to better protect the public. One comment specifically stated that FSIS should take action to better identify the source of contamination and to remove associated adulterated product from commerce.

Other commenters stated that additional steps could also be taken to improve traceback methodology in cases where a positive sample is taken from a production lot of ground beef created from multiple sources. Specifically, some commenters suggested that when a production lot of ground beef that was produced from multiple source lots tests positive, FSIS should test any remaining unopened trim from the source production lots to identify which source lot is implicated by the positive ground beef sample.

Other commenters asked questions about the new traceback methodology and requested that FSIS continue to share information about the new methodology and clarify issues concerning the new methodology. Several commenters agreed that establishments should develop or use process control procedures based on HEP criteria that indicate higher than expected rates of positive E. coli O157:H7 test results. Some commenters raised questions concerning whether N60 sampling procedures are capable of detecting contaminated product on a routine basis. Finally, some commenters recommended that FSIS collect information on suppliers at the time of sample collection, rather than after the sample is confirmed positive for E. coli O157:H7 to expedite all necessary investigation and traceback activities.

Improved Traceback Procedures: On October 8, 2010, in response to comments received at the public meeting, FSIS issued instructions to inspection program personnel to record information on the source materials and on the suppliers at the time they sample ground beef or bench trim for E. coli O157:H7 (FSIS Notice 58-10). With issuance of the October 8, 2010 notice, FSIS changed its procedures so that inspection program personnel no longer wait for a positive test result before they gather supplier information. FSIS agreed with comments that had been submitted in response to the public meeting that collecting supplier information at the time the sample is collected would better serve FSIS's goal to respond to FSIS presumptive positive results by identifying all affected product and all potential suppliers as quickly as possible to protect public health.

FSIS intends to implement additional improved procedures consistent with the procedures it discussed at the public meeting. As is discussed above, inspection program personnel will continue to collect and document information on suppliers at the time of sample collection. Using the supplier information, EIAOs will then conduct traceback investigations at establishments that produced the E. coli O157:H7 positive product and at suppliers that provided source materials for ground beef or bench trim that FSIS has found positive. These traceback investigations will begin as soon as possible, based on presumptive positive results and supplier information from the producing establishment. EIAOs will visit both the establishment that produced the positive product and the supplier slaughter establishment and gather relevant information about the production of the product, including use of anti-microbials and prevention of cross contamination, sanitary conditions, and relevant purchase specifications.

As part of their traceback investigations, EIAOs will review establishment test results to determine whether the establishment has experienced a HEP. If the establishment has developed its own supportable HEP criteria, the EIAOs will determine whether it has experienced a HEP based on the establishment's HEP criteria. If it has not, EIAOs will determine whether the establishment has experienced a HEP based on the FSIS criteria discussed below. The occurrence, or lack of occurrence, of a HEP will be one factor that EIAOs will consider when investigating at the establishment that produced positive product or supplied product to an establishment that produced positive product.

Based on all the information gathered, EIAOs will present findings to the District Manager on which to determine whether adulterated product has entered commerce. The EIAO will also make recommendations concerning whether regulatory and enforcement actions are warranted. The District Manager will then determine whether adulterated product entered commerce, and if it has, whether to contact the FSIS Recall Management Staff and whether enforcement actions are appropriate. Consistent with Agency procedures, the Recall Management Staff will lead any Agency requests that establishments recall product.

As is discussed above, EIAOs do not do this type of investigation now until they conduct FSAs. FSAs are scheduled approximately 30 days after the confirmed positive results become available, so they are much later than the investigations FSIS intends to conduct. Also, during the FSAs at this time, EIAOs do not ask all the focused questions FSIS intends to instruct them to ask as part of this new procedure. Finally, EIAOs do not currently evaluate whether the establishment has experienced a HEP on a consistent basis.

Recalls from sole source suppliers: Also in response to comments to the public meeting concerning the need to eliminate contaminated source material from commerce, FSIS intends to implement a new recall policy to request that supplier establishments recall product if all of the following circumstances occur:

(1) FSIS or other Federal or State agencies find raw ground beef positive for E. coli O157:H7 at a grinding establishment;

(2) FSIS determines that E. coli O157:H7 cross-contamination was unlikely to have occurred at the grinding establishment where the sample was taken (based on FSIS's assessment of the grinding establishment's handling practices);

(3) FSIS determines that the grinding establishment did not combine material from multiple source lots to create the lot of product that tested positive;

(4) After conducting traceback to identify the slaughter and trim fabrication supplier that provided the sole source material, FSIS determines that the supplier or downstream users split the implicated lot before sending it to the establishment where the positive sample was taken; and

(5) Some portion of the split lot sent to the grinder was sent into commerce for further processing into product that does not receive a full lethality to eliminate E. coli O157:H7 in a federally inspected establishment.

If all of these circumstances occur, FSIS intends to request a recall from the slaughter or trim supplier establishment. If cross contamination did not occur at the grinding establishment, the source materials would be considered adulterated because, based on evidence and available data, contamination occurred at the slaughter or trim establishment.

In the two-year period between January 1, 2009, and December 31, 2010, 65 Agency samples of ground beef (collected as part of the routine and follow-up sampling programs) tested positive for E. coli O157:H7. Of those 65 positive samples, 41 of them (63.1%) were taken from production lots created using source material from a sole supplier. Twelve of the 41 sole suppliers were self suppliers, meaning that slaughter, trim fabrication, and grinding were done at the same establishment. Out of the 41 sole suppliers, 29 were external supplier establishments. The remaining 24 of the 65 positive samples (36.9%) were taken from production lots created using source material from multiple suppliers. Therefore, there were 29 external sole suppliers that provided the source materials for positive ground product. If all the criteria for a recall were in place, FSIS would have requested 29 additional recalls. However, it is likely that some of these suppliers did not split lots, so all of the source materials from the production lot involved would have gone to the grinder that produced the positive product. If the suppliers did not split the lot, this policy would not result in any additional recalls. Any additional recalls under these circumstances are likely to better prevent the public from consuming adulterated product.

Based on the 2009-2010 data, a significant number of ground product lots that FSIS found positive were produced from source materials from sole source suppliers. However, in some circumstances, the grinding establishment may have combined material from multiple source lots to create the lot of product that tested positive. Under these circumstances, the new recall policy would not apply.

FSIS agrees with commenters to the public meeting that removing from commerce source materials that may be contaminated with E. coli O157:H7 is critically important. In situations where contamination most likely occurred at the slaughter establishment that produced the source materials, removing from commerce those source materials used to produce E. coli O157:H7 positive product is scientifically sound. E. coli O157:H7 is an enteric pathogen; therefore, contamination may occur during the slaughter process, from transfer of contamination from the hides, hooves, and gut of cattle. Contamination may occur through cross contamination at the grinder; however, if there is no evidence of cross contamination at the grinder, contamination most likely occurred at the slaughter or trim establishment. FSIS is not aware of any circumstance in which a split lot contributed to a reported illness. Regardless, FSIS believes that this new recall policy will better protect the public from consumption of E. coli O157:H7 contaminated product because it will better ensure that source materials that are contaminated with E. coli O157:H7 are removed from commerce. FSIS has requested recalls from sole suppliers that provided source materials for product found positive at grinders under specific, special circumstances, but not as a general rule. FSIS requests comment on this new recall policy before implementing it as a standard procedure and requests comment on the costs that would result from this recall policy.

High event periods: Most establishments use testing that includes an enrichment step followed by differential screening specific to STEC organisms, particularly E. coli O157:H7 or their associated virulence markers (e.g., eae and stx genes). Positive results during these screening tests require further testing to detect E. coli O157:H7. If an establishment does not perform additional testing, it should treat lots that test positive in screen tests as positive. Similarly, FSIS considers those results positive for E. coli O157:H7 if not confirmed negative. Therefore, the discussion below refers to shiga toxin-producing E. coli (STEC) organisms or virulence markers, in addition to E. coli O157:H7.

HEPs are periods in which slaughter establishments experience a high rate of E. coli O157:H7 (or STEC organisms or virulence markers) in trim samples from production lots containing the same-source materials. That is, the trim was produced from one or more carcasses slaughtered and dressed consecutively or intermittently within a defined period of time (e.g., shift). E. coli O157:H7 contamination is generally point-source contamination that occurs sporadically as a consequence of handling during hide removal and dressing of the carcass. However, during HEPs, the contamination has become more widespread. HEPs may stem from a higher than expected level of contamination on hides, a failure of prevention mitigations, or cross contamination of product. A high rate of positives in trim is problematic because the trim is typically used across multiple production lots, is handled by employees, and is therefore likely to contaminate common conveyor belts and equipment. Also, such high rates of positives or HEPs may mean that a systemic breakdown of the establishment's production process may have occurred, and that insanitary conditions existed at the establishment during these periods. Such insanitary conditions may affect the safety of intact (primal and subprimal) cuts, trim, and other beef components used in the production of ground beef. In response to comments from the public meeting that supported the implementation of new traceback procedures to better identify contaminated source materials, FSIS intends to provide more specific instructions to EIAOs concerning HEPs that may occur at slaughter establishments that produced source materials for product that FSIS has found positive for E. coli O157:H7. FSIS will issue the new instructions as a notice or directive to its personnel. The new procedures it intends to implement are discussed below. As is discussed below, FSIS is also providing updated guidance to establishments on how to identify HEPs. FSIS considered comments submitted on the guidance and believes that the guidance is now more useful to industry to help it identify HEPs, avoid recalls, and prevent adulterated product from entering commerce.

To help develop the operational criteria for industry to use to identify HEPs and for EIAOs to consider when conducting traceback procedures, FSIS examined industry data collected by FSIS inspection personnel from the top 33 slaughter establishments, representing 80 percent of industry production volume (number of cattle slaughtered).

The data from the 33 establishments show clustering of positives results. Of the 33 establishments, 32 responses were received, 19 had clear definitions of a HEP, 2 had definitions that were incomplete because they did not specify a frame of time (which we interpreted to be a day), 10 had unclear definitions of a HEP, and 1 did not have a definition. Of the 21 establishments that had clear definitions, 7 were using a 5 percent threshold definition;  5 9 indicated a threshold of 1-3 positive results a day or shift; 2 used between 5-10%; and 3 had definitions greater than 10%.

Based on these results, FSIS selected a target of 5% for the HEP criteria. Because FSIS did not want to define HEP criteria that would be more rigorous than those of a large number of establishments, we did not select a lower target. FSIS set criteria to help identify exceptional events of poor processing. FSIS did not select a higher target (e.g., 10%) because such a target we believe could result in many cases where poor processing, as defined by most of the industry, would not be detected as HEP.

FSIS intends to identify in the guidance and in instructions to EIAOs two types of HEP that may indicate out-of-control situations in the establishment's production process based on establishment results. As noted above, 10 of the establishments had unclear definitions of HEPs, and one had no definition. If establishments use FSIS's criteria, FSIS would find their HEP definitions supportable. Below are the two types of HEPs.

During a systemic break-down situation, establishments may identify more product that needs to be assessed to determine whether it may be adulterated than in a localized HEP. A localized HEP may affect only the production of one lot, while a systemic break-down may affect more product. Also, a localized HEP may indicate an isolated problem (such as improper application of an anti-microbial in one lot); a systemic HEP may indicate a broader problem (such as systemic failure to prevent cross contamination among carcasses).

FSIS is setting out criteria for identifying HEPs. These criteria will be especially useful for establishments that have rigorous testing programs. Beef slaughter and fabrication establishments that manufacture 50,000 pounds or more of trimmings daily are likely to conduct sufficient verification testing on same source materials to be able to determine whether a HEP occurred based on the criteria below. Lower volume establishments may choose to test frequently enough to use these criteria. If not, the guidance includes general information for lower volume establishments.

The above criteria are based on high degrees of confidence (establishing sufficient statistical evidence) that the process percentage exceeded 5% during some period. For the systemic HEP based on daily testing of at least 60 samples  6 and the local HEP guidance, FSIS used close to 99 percent confidence for establishing sufficient statistical evidence. 7 For the systematic short-term HEP (based on 30 samples), FSIS selected about 99.95% confidence for asserting sufficient statistical evidence. The reason for this high degree of confidence is that FSIS wanted to have a short-term HEP criterion to help establishments identify periods of serious processing problems.

Establishments may use the guidance that FSIS has provided as criteria for determining whether they have experienced a HEP. However, the establishment-specific process percent positive could be different than the FSIS criteria (assuming that the sampling plan and analyses are described as above). Consequently, a specified percent positive for a given establishment should be identified and justified if other than that stated by FSIS if past results indicate that a different percent positive was being achieved consistently, and product has low likelihood of being adulterated. Deviations from the previously obtained percent positive should be construed as presumptive evidence that the process is out of control and would warrant investigation to find and eliminate any potential causes for the positive results. As part of their supporting documentation for their hazard analysis (9 CFR 417.5 (a)), FSIS recommends that establishments document the criteria they use to identify HEPs.

Consistent with information FSIS presented at the March 2010 public meeting discussed above, FSIS intends to instruct EIAOs to conduct an investigation at establishments that produced positive E. coli O157:H7 product and at establishments that provided the source materials used to produce that product. These traceback investigations will begin as soon as possible, based on presumptive positive results and supplier information at the producing establishment. Through these new procedures, FSIS will investigate the reasons for positive results on a more timely and thorough basis than the Agency does currently. At slaughter establishments that produced positive product or source materials used in the production of positive product, EIAOS will consider whether the establishment has experienced a HEP.

A HEP indicates that production lots of same source material that are presumed to be microbiologically independent (based on test results or other criteria) may no longer be microbiologically independent. As noted above, in such cases, these production lots may be considered to be potentially contaminated with E. coli O157:H7, even if the establishment has negative test results. During their investigations, EIAOs will look at establishment test results and will determine whether the establishment has its own HEP criteria. FSIS intends to instruct EIAOs that when a HEP has occurred based on the establishment's criteria or FSIS criteria, they are to determine whether the establishment considered whether negative tested lots of trimmings are releasable, and whether primal and sub-primal product produced from the same source materials as the trimmings may be positive for E. coli O157:H7, particularly if the establishment does not have controls in place to ensure that the primal and sub-primal product is not used for non-intact purposes.

If a HEP has occurred, FSIS intends to instruct the EIAO to evaluate whether the establishment verified that all controls in place in the slaughter process that are necessary to prevent E. coli O157:H7 are working as intended. Such controls may include measures to reduce the pathogen load on incoming animals, measures to ensure that contamination of the carcass is prevented during slaughter or dressing procedures, effective decontamination or pathogen reduction treatments (also referred to as “antimicrobial treatments”), and measures to minimize carcass-to-carcass contact and cross contamination.

Also, if a HEP has occurred, FSIS intends to instruct the EIAO to evaluate whether the establishment found the cause for the HEP and has taken corrective action to prevent future HEPs from recurring.

Finally, if the establishment has experienced a HEP during a “high prevalence season” (from spring into early autumn), FSIS intends to instruct the EIAO to determine whether the establishment increased the frequency of monitoring and verification of both slaughter and dressing procedures and pathogen reduction treatments, and whether the establishment modified its sampling and verification testing programs during the high prevalence season to increase the likelihood of finding the pathogen.

As stated above, the EIAO will present to the District Manager the findings concerning HEPs and all other findings and recommendations, including any evidence indicating that adulterated product has likely entered commerce. Similarly, based on the HEP information, as well as other information collected, the EIAO will make recommendations concerning what regulatory or enforcement actions may be warranted. In addition, if the District Manager determines that adulterated product entered commerce, the Recall Management Staff will lead any Agency requests that establishments recall product. FSIS expects to complete the investigation and take all necessary enforcement actions within one month.

We note that this Notice imposes no new requirements for establishments related to HEPs. The new EIAO instructions and investigation procedures described are only intended to improve and expedite FSIS traceback procedures.

Possible New Procedures To Identify Suppliers: In response to comments, FSIS intends to assess the merits and resource implications of conducting additional traceback activities. For example, FSIS intends to determine whether it can make better use of the results of establishment (versus FSIS) testing for E. coli O157:H7 and other microorganisms and other establishment data that they may collect to evaluate their sanitary dressing procedures. FSIS requests comment on how the Agency could better evaluate this data and use it to inform establishments that problems may be developing or to advise establishments to take action to prevent the creation of insanitary conditions or the production of adulterated product in the future. Inspection program personnel currently review establishment test results on a weekly basis (FSIS Directive 5000.2). FSIS is considering issuing clarifying instructions to these personnel to look for increasing positive results that should be raised to the establishment's attention. FSIS also intends to conduct a study to test product from unopened containers or purge material (that is, remaining liquid, fat, and meat particles in containers or combo bins after trim contents have been removed) from suppliers' product for E. coli O157:H7. The purpose of this study will be to identify the source of E. coli O157:H7 positive raw ground beef when material from multiple suppliers was used to create the sampled ground beef that FSIS has found positive for E. coli O157:H7.

In October 2008, FSIS issued draft guidance entitled, “Label Policy Guidance for N60 Testing Claims for Boneless Beef Manufacturing Trimmings (`Trim') Concerning E. coli O157:H7,” and draft guidance entitled, “Compliance Guideline for Sampling Beef Trimmings for Escherichia coli O157:H7” and requested comments on these documents. FSIS also held a public meeting to discuss the guidance and other topics concerning E. coli O157:H7. FSIS carefully considered the comments received and has responded to comments below.

FSIS has posted the revised guidance on its Significant Guidance Documents Web page http://www.fsis.usda.gov/Significant_Guidance/index.asp. FSIS encourages those who are interested in using sampled and tested claims to avail themselves of this guidance document when preparing applications for sketch approval, and when using a sketch approved sampled and tested claim. Similarly, FSIS encourages establishments to begin using the trim sampling guidance. FSIS welcomes comments on this guidance document. The Agency will consider carefully all comments submitted and will revise the guidance document as warranted.

This guidance, entitled “Compliance Guideline for Establishments Sampling Beef Trimmings for Shiga Toxin-Producing Escherichia coli (STEC) Organisms or Virulence Markers,” is meant to help slaughter establishments develop and implement sampling and testing programs for E. coli O157:H7 (or STEC organisms or virulence markers) in beef manufacturing trimmings that are sampled using the N60 sampling method or similar methods. FSIS recommends that establishments identify HEP criteria so that they can determine whether they need to withhold product from commerce when a HEP has occurred, because a HEP may indicate more widespread adulteration of product, beyond the product found positive. If establishments identify and respond to HEPs, they will minimize the chance that they release adulterated product into commerce.

Although this document also provides general information for non-slaughter establishments that produce or receive trimmings, the HEP information in the guidance only applies to slaughter establishments that manufacture trim. The HEP guidance will be most useful to slaughter and fabrication establishments that manufacture 50,000 pounds or more of trimmings daily because they are likely to conduct sufficient testing on same source trimmings to be able to determine whether a HEP has occurred. Smaller volume slaughter and fabrication establishments can also use the FSIS suggested criteria, particularly those that involve 10 and 30 samples. Non-slaughter establishments will not know if problems with slaughter and dressing procedures have contributed to a HEP because they do not have the necessary information from the establishment that slaughtered the cattle. FSIS recommends that a slaughter and fabrication establishment conduct sampling and testing of trim at a frequency sufficient to find evidence of contamination surviving the slaughter and dressing operation (optimally every production lot) to best ensure that adulterated product does not enter commerce. Verification testing results on trim are likely the best available information a slaughter establishment can use to determine the effectiveness of its slaughter and dressing operation.

Comment: Industry commenters disagreed with the “event day” or “hot day” discussion FSIS presented in the guidance to illustrate the number of positive results within a set number of samples that would indicate that a process is out of control. These commenters were concerned that the criteria would trigger regulatory criteria and recalls. A consumer group was concerned that the compliance guide suggested establishments would not have to investigate every positive but could, instead, just investigate positives during HEPs.

Response: Identifying a HEP is an adequate basis for determining whether a process is out of control. A high number of positives within a limited number of samples may indicate that a systemic problem may have occurred. To ensure that FSIS provides guidance for identifying HEPs that would be useful to establishments, FSIS has gathered information from inspectors at the 33 largest beef slaughter establishments and revised the guidance to reflect this information.

The guidance clarifies that establishments are required to investigate all positive results based on 9 CFR 417.3. In addition, the guidance recommends that establishments take additional actions in response to HEPs. The guidance explains that if the establishment has experienced a HEP, it should carefully investigate to find all contributing causes. This type of investigation would be more involved than a follow-up investigation when an occasional positive result is found.

Comment: Consumer organizations stated that establishments' testing cannot replace effective prevention strategies and process control. Industry commenters noted that microbiological testing is not designed to test the safety of beef products, but rather, such testing is to verify that controls are in place. One commenter submitted the Beef Industry and Food Safety Council (BIFSCo) “Best Practices for Using Microbiological Sampling,” a guidance document in conjunction with its comments.

Response: FSIS agrees with the comments that establishment testing is just one verification activity that establishments can use to verify that their food safety system adequately addresses E. coli O157:H7. Nonetheless, it is important to underscore that microbiological testing is likely the best method for system verification as it relates to microbial hazards. FSIS agrees that the BIFSCo guidance is useful and has included a link to it in the compliance guidelines so that users can quickly access that guidance.

Comment: A consumer group commented that FSIS's N60 program for sampling beef manufacturing trimmings is ineffective because it is not based on an accurately measured prevalence rate. The commenter also stated that N60 sampling does not allow the Agency's testing to detect E. coli O157:H7 and, therefore, should not be used to verify product safety or that a process is in control.

Response: FSIS agrees that information on national prevalence is important for properly designing a sampling program. 8 However, a national prevalence estimate is not sufficient information to determine how to collect a sample from a lot, owing to the distinction between determining how many lots to test and how to collect a sample from each lot. In other words, prevalence data could inform how many lots to test nationwide, but not how to collect a sample from each lot. A sampling program, such as FSIS's trim sampling program, is a different concept than a sample collection method, such as N60.

FSIS's N60 sampling of beef trim and testing of trim for E. coli O157:H7 is only one of a number of verification activities that FSIS conducts regarding establishment process controls for E. coli O157:H7. FSIS sampling of beef trim works along with inspection and other verification activities, including FSIS sampling of ground beef and other ground beef components and the review of establishment testing results, to detect and reduce E. coli O157:H7 in beef products. FSIS's mission is not to screen the food supply through testing but to verify that safe and wholesome food is produced through inspection activities.

Comment: Another industry commenter disagreed that aerobic plate counts (APCs) are an indicator of process control for reducing E. coli O157:H7. The commenter stated that there is no significant correlation between E. coli O157:H7 and APCs.

Response: FSIS agrees that there is not a significant correlation between E. coli O157:H7 and APCs. However, as is stated in the guidance, FSIS continues to believe that it is useful for beef establishments to conduct verification testing for associated organisms that include E. coli O157:H7 (e.g., a screen methodology for pathogenic E. coli ) and to maintain records of results as a quality control activity. Measurements of ubiquitous organisms such as Enterobacteriacea, APC, or generic E. coli can be used to evaluate the effectiveness of process controls in limiting or eliminating microbial contamination. Frequent measurements of APC counts may represent a short-term trend, which would be useful for quality control, both before and after the sanitary dressing processes. However, such measurements, while helpful for ensuring microbial process control, cannot be used as a substitute for determining the actual presence or absence of E. coli O157:H7 in the final product.

Comment: Some comments supported changes to traceback activities discussed above. For example, one consumer group supported FSIS capturing information for all positive results, including results for industry sampling programs.

Response: See discussion above under “Improved Traceback Procedures.”

Sampled and Tested Claims Guidance: This document provides guidance on the use of labels bearing an FSIS sketch approved E. coli O157:H7 sampled and tested claim on beef trim. As is explained in the guidance, such special labeling claims are voluntary. An establishment may use such claims when it demonstrates that they are truthful and not misleading (9 CFR 317.8(a)). FSIS must approve such claims before the establishment may use them on labels (9 CFR 317.4(a)). This guidance document addresses label claims that are not intended to be displayed to consumers. FSIS may approve E. coli O157:H7 sampled and tested claims on trim that goes to retail stores, for example to a retailer who purchases the trim for grinding. However, FSIS will not approve such a label claim for display to consumers because it may be misleading to consumers by suggesting that the end product is free of the pathogen or may not need to be cooked thoroughly.

A labeling claim asserting that beef trim has been sampled, tested, and found negative for E. coli O157:H7 will provide receiving establishments with information regarding the sampling and testing of beef trim for that pathogen conducted by supplier establishments.

Sampling and testing for E. coli O157:H7 is intended to provide evidence regarding the effectiveness of HACCP measures in addressing the pathogen. Therefore, in order for a sampled and tested claim to be truthful and not misleading, the establishment asserting the claim must have incorporated into its HACCP system measures designed to control for E. coli O157:H7, and it must use sampling and testing methodologies that are designed to verify the effectiveness of those measures.

The final guidance document provides assistance to establishments on the use of labels bearing an FSIS sketch approved sampled and tested claim. It provides several examples of labeling claim language that may be appropriate under different circumstances. The final guidance also suggests the kind of documentation that establishments seeking sketch approval may submit to demonstrate that a sampled and tested claim would be truthful and not misleading.

Comment: Several members of industry questioned the connection between documentation of HACCP measures related to E. coli O157:H7 and the truthfulness of a sampled and tested claim. These comments argued that it is not necessary to provide such extensive documentation in order to demonstrate that a sampled and tested claim is truthful and not misleading. They also stated that including extensive documentation as part of an application for sketch approval would be burdensome.

Response: A labeling claim that beef trim has been sampled, tested, and found to be negative for E. coli O157:H7 is not a representation that the labeled beef trim is free of E. coli O157:H7; rather, it is a representation that sampling and testing of the production lot from which the beef trim was derived has demonstrated that the production lot was produced under a HACCP system with measures in place that effectively control for the pathogen. Accordingly, a sampled and tested claim is only truthful and not misleading if indeed such measures are in place, and if the sampling and testing program is designed to verify the effectiveness of those measures.

To assist interested establishments to obtain sketch approval of sampled and tested claims, the final guidance retains a description of the HACCP system-related documentation that FSIS believes would demonstrate that a sampled and tested claim is truthful and not misleading. FSIS made some revisions to the guidance for the sake of clarity.

Comment: Several industry representatives argued that the information to be included on a label bearing a sampled and tested claim should be simpler than what was described in the draft guidance. Some specific examples of information the commenters argued need not be included are: (1) Lot size information; (2) lot identification information; and (3) information indicating whether a production lot which was formed by combining beef trim from two or more source production lots was sampled after the source lots were combined.

Response: In response to the three specific concerns raised above: (1) Lot size information has been removed from the final version of the labeling guidance. This information was initially included as a suggested means of indicating to receiving establishments whether the labeled beef trim they receive consists of all or only a portion of a sampled production lot. In light of industry comments reflecting the practical difficulty of regularly changing labeling text to reflect the varying sizes of production lots, this suggestion has been replaced with guidance recommending a simple statement informing receiving establishments whether the labeled beef trim consists of an entire production lot or a portion of a split lot. (2) Including lot identification information on labels containing sampled and tested claims is important to ensure that such claims are truthful and not misleading because this information allows the labeled beef trim to be traced to a specific production lot. Therefore, the final version of the policy guidance document retains this suggested labeling information. (3) FSIS believes that it is important for a sampled and tested claim to include a statement specifying whether (a) the final formulation of labeled beef trim was sampled and tested, or (b) the source lots were sampled and tested before being combined. This information is relevant to whether a claim is truthful and not misleading because it identifies which production lot or lots have been produced using HACCP measures that effectively control for E. coli O157:H7. FSIS agrees with several comments that the Agency needs to clarify this portion of the draft guidance. Therefore, FSIS has removed the “twice tested” discussion and replaced it with a suggestion that sampled and tested claims asserted on beef trim product formulated by combining two or more source lots state whether sampling and testing was conducted on the final formulation or on the source lots.

Comment: Many comments argued that the guidance should better define what constitutes N60 sampling methodology, and what constitutes an FSIS-equivalent testing method.

Response: The draft guidance referred specifically to the use of N60 sampling in connection with use of a sampled and tested claim. The final guidance does not specify that N60 sampling must be done in order to use a sampled and tested claim. Instead, the final guidance emphasizes that, in order for the claim to be truthful and not misleading, the sampling and testing program must be designed to verify the effectiveness of an establishment's HACCP measures that control for E. coli O157:H7. FSIS believes that the sampling and testing methodologies it uses, including N60 sampling, achieve this goal. Therefore, the final policy guidance refers to documents that provide detailed descriptions of FSIS sampling and testing methodologies. However, if an establishment uses different sampling or testing methodologies that the establishment believes provide reliable verification of the effectiveness of HACCP measures designed to control for E. coli O157:H7, and therefore that use of those methodologies will ensure that a sampled and tested claim is truthful and not misleading, then the establishment may include in its application for sketch approval documentation describing why its methodologies are equivalent to FSIS methodologies. To assist establishments wishing to demonstrate the equivalence of their sampling or testing methodologies, the final policy guidance refers to a separate guidance document that provides assistance to industry in conducting validation studies for pathogen detection methods: http://www.fsis.usda.gov/PDF/Validation_Studies_Pathogen_Detection_Methods.pdf.

USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, or audiotape.) should contact USDA's Target Center at 202-720-2600 (voice and TTY).

To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). USDA is an equal opportunity provider and employer.

FSIS will announce this notice online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.

FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to passwordprotect their accounts.

Purpose and Need for Action

The HFRA recognizes healthy forests or forest health as an integral part of forest management. The proposed action responds directly to forest health objectives as described in the HFRA. The purpose of this project is to reduce the effects from current mountain pine beetle infestation in forested stands dominated by lodgepole pine trees and to reduce the susceptibility of vegetation to high-intensity wildfire and further mountain pine beetle attacks. The project is needed to: (1) Salvage forest products from, and manage stand densities on, forested lands classified as suitable for timber production to keep them positively contributing to the national forest's allowable sale quantity; (2) Reduce the effects of tree mortality associated with the mountain pine beetle epidemic to restore healthy ecological conditions and scenic quality; (3) Accelerate regeneration of forested stands killed by the mountain pine beetle; and (4) Manage hazardous fuel loading associated with the mountain pine beetle epidemic and salvage operations to minimize the potential for large, high intensity/high severity wildfires.

This action responds to the goals and objectives outlined in the Wasatch-Cache National Forest Land and Resource Management Plan (“Forest Plan”), and helps move the project area towards desired conditions described in that plan.

The proposed project includes treatment of approximately 4,300 acres of aspen and lodgepole communities using timber harvest, prescribed fire, and mechanical fuels treatments. Sanitation salvage would be used on approximately 1,730 acres, clearcuts would be used on approximately 1,241 acres, sanitation salvage with pile and burn would be used on approximately 76 acres, clearcut with pile and burn would be used on approximately 40 acres, roadside salvage would occur on approximately 695 acres, and approximately 514 acres would be undergo a thin, pile, and burn prescription.

Proposed treatments are intended to reduce both the amount and continuity of woody fuels, to remove hazard trees, to harvest beetle-killed or infested trees, and to create a mix of tree ages and species.

The proposed action would retain habitat for sensitive and other species, such as northern goshawks, where needed. The proposed action is also expected to make improvements to visual quality. Treatments in the vicinity of private land would be intended to reduce the threat of wildfire to human life and property.

Access to treatment units, as currently mapped, is anticipated to involve approximately 3.1 miles of new specified road construction, approximately 10.7 miles of temporary road construction, approximately 6.7 miles of additional temporary road use on the existing road prism, and approximately 2.6 miles of road reconstruction. Approximately 3.8 miles of easements through private land would be needed for access to units 4, 20, and 79.

In addition to the proposed action, a no action alternative will be considered. This alternative would continue current management without the actions of this proposal. Because this project is being analyzed via the HFRA, one additional alternative that addresses the purpose and need for the project may be developed in response to issues generated during the scoping process.

Uinta-Wasatch-Cache National Forest forest supervisor.

The decision to be made is whether or not to implement vegetation restoration treatments in the Smiths Fork project area, and if so, to what degree and where.

Preliminary issues are the effects of treatments on wildlife habitat, and the effects of insect and disease outbreaks on current forest health.

This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. This project is not subject to the notice, comment, and appeal process found at 36 CFR part 215. Rather, it is subject to the predecisional administrative review process found at 36 CFR part 218. This process provides the opportunity to resolve issues raised in an objection and identify potential solutions. Only persons who submit specific written comments on the proposed action during the 30-day comment period will be eligible to file an objection. This comment period represents the only opportunity for the public to comment on this proposal prior to the objection process. The opportunity to comment will end 30 days after a legal notice announcing the request for scoping comments is published in the Salt Lake Tribune, which is the newspaper of record.

The meeting is open to the public. Council discussion is limited to Forest Service, National Institute of Food and Agriculture staff and Council members. However, persons who wish to bring forestry research matters to the attention of the Council may file written statements with the Council staff before or after the meeting.

Title: Expanded Food and Nutrition Education Program.

OMB Number: 0524-0044.

Expiration Date of Current Approval: 07/31/2012.

Type of Request: Intent to seek approval to extend the currently approved information collection for three years. There are no planned revisions.

Abstract: The USDA's NIFA Expanded Food and Nutrition Education Program (EFNEP) is a unique program that began in 1969 and is designed to reach limited resource audiences, especially youth and families with young children. Extension professionals train and supervise paraprofessionals and volunteers who teach food and nutrition information and skills to limited resources families and youth. EFNEP operates through the 1862 and 1890 Land Grant Universities in all 50 states, the District of Columbia, and in American Samoa, Guam, Micronesia, Northern Marianas, Puerto Rico, and the Virgin Islands.

The objectives of EFNEP are to assist limited resource families and youth in acquiring the knowledge, skills, attitudes, and changed behaviors necessary for nutritionally sound diets, and to contribute to their personal development and the improvement of the total family diet and nutritional well-being.

NIFA sponsors an integrated data collection process that is used at the county, state, and federal level. The current data collection system, the Nutrition Education Evaluation and Reporting System (NEERS), captures EFNEP impacts. Its purpose is to gauge if the federal assistance provided has had an impact on the target audience. It also enables EFNEP staff to make programmatic improvements in delivering nutrition education. Further, the data collected provides information for program management decisions and diagnostic assessments of participant needs. Specifications for this system were developed by a committee of representatives from across the United States and are in compliance with Federal standards for maintaining, collecting, and presenting data on race and ethnicity and protecting personally identifiable information.

NEERS stores information on: (1) Adult program participants, their family structure, and dietary practices; (2) youth group participants; and (3) staff. NEERS consists of separate software sub-systems for the County and the State levels (State also refers to U.S. Territories). Data is exported electronically to the State-level system. University staff generates State-level reports for State-level stakeholders and to guide program management decisions. They also export State-level data electronically to the Federal office for State and National assessments of the program's impact. The State compiled data is aggregated using statistical software and then is used to create National reports which are made available to the public.

There are no revisions to the currently approved collection.

The evaluation processes of EFNEP remain consistent with the requirements of Congressional legislation and OMB. The Government Performance and Results Act (GPRA) of 1993 (Pub. L. 103-62), the Federal Activities Inventory Reform Act (FAIR) (Pub. L. 105-207), and the Agricultural, Research, Extension and Education Reform Act (AREERA) of 1998 (Pub. L. 105-185), together with OMB requirements, support the reporting requirements requested in this information collection. One of the five Presidential Management Agenda initiatives, Budget and Performance Integration, builds on GPRA and earlier efforts to identify program goals and performance measures, and link them to the budget process. The FAIR act requires the development and implementation of a system to monitor and evaluate agricultural research and extension activities in order to measure the impact and effectiveness of research, extension, and education programs. AREERA requires a performance evaluation to be conducted to determine whether federally funded agricultural research, extension, and education programs result in public goods that have national or multistate significance.

Estimate of Burden: The number of respondents has increased from 74 to 75 institutions (e.g., state responses), thus constituting a total annual estimated burden of 93,225 hours for this data collection process—for participant education and data entry, aggregation, and reporting. Burden estimates are reflective of the previous version of the data collection system. The burden for respondents was estimated through feedback from a survey sent to nine institute-level EFNEP Coordinators. Six surveys were returned. Burden takes into account only the information collected in aggregate from the institutions and the record keeping activities that take place in order to provide the aggregated data; it does not include burden related to data entry at the local level. Local data is used by the county and institute levels to provide feedback to participants and to guide county and institute level program management, impact and accountability decisions and reporting.

Comments: 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; (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.

Obtaining a Copy of the Information Collection: A copy of the information collection and related instructions may be obtained free of charge by contacting Gidel Mendez as directed above.

The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. This notice identifies information collections that RUS is submitting to OMB for extension.

Comments are invited on: (a) Whether this 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 respondents, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Director, Program Development and Regulatory Analysis, USDA Rural Development, Stop 1522, 1400 Independence Ave. SW., Washington, DC 20250-1522. FAX: (202) 720-8435.

Title: Operating Reports for Telecommunications and Broadband Borrowers.

OMB Control Number: 0572-0031.

Type of Request: Revision of an existing information collection package.

Abstract: Rural Utilities Service (RUS), an agency delivering the U.S. Department of Agriculture (USDA) Rural Development Utilities Programs, is a credit agency. RUS makes mortgage loans and loan guarantees to finance electric, broadband, telecommunications, and water and waste facilities in rural areas. In addition to providing loans and loan guarantees, one of the Agency's main objectives is to safeguard loan security until the loan is repaid.

This collection of information covers the Telecommunications Operating Report, the Broadband Operating Report, and RUS Form 674, “Certificate of Authority to Submit or Grant Access to Data.” The data collected via the Telecommunications Operating Report is collected through the USDA Data Collection System. The data collected via the Broadband Operating Report is collected through the USDA Broadband Collection and Analysis System. The data collected via the Telecommunication and Broadband Operating reports is required by the loan contract and provides Rural Development with vital financial information necessary to ensure the maintenance of the security for the Government's loans, and statistical data to enable the Agency to ensure the provision of quality telecommunications and broadband services as mandated by the Rural Electrification Act (RE Act) of 1936. The data collected via the operating reports provides financial information to ensure loan security consistent with due diligence. These functions are essential to protect loan security and to achieve objectives of the RE Act.

The data collected via RUS Form 674 provides information to the Agency to allow Rural Development Electric, Telecommunications, and Broadband program Borrowers to file electronic Operating Reports with the Agency using the USDA Data Collection System. RUS Form 674, accompanied by a Board Resolution, identifies the name and USDA eAuthentication ID for a certifier and security administrator who will have access to the USDA Data Collection System for purposes of filing electronic Operating Reports. The information collected on the RUS Form 674 is submitted in hard copy by Borrowers only when revisions are required or, in the case of a first time Borrower, when initially submitting the data.

Estimate of Burden: Public reporting for this collection of information is estimated to average 3.45 hours per response.

Respondents: Businesses or other for-profit and not-for-profit Institutions.

Estimated Number of Respondents: 676.

Estimated Number of Responses per Respondent: 1.36.

Estimated Total Annual Burden on Respondents: 2,806.

Title: Distance Learning and Telemedicine Loan and Grant Program.

OMB Control Number: 0572-0096.

Type of Request: Revision of a currently approved information collection package.

Abstract: The Rural Utilities Service's (RUS) Distance Learning and Telemedicine (DLT) Loan and Grant program provides loans and grants for advanced telecommunications services to improve rural areas' access to educational and medical services. The various forms and narrative statements required are collected from the applicants (rural community facilities, such as schools, libraries, hospitals, and medical facilities, for example). The purpose of collecting the information is to determine such factors as eligibility of the applicant; the specific nature of the proposed project; the purposes for which loan and grant funds will be used; project financial and technical feasibility; and, compliance with applicable laws and regulations. In addition, for grants funded pursuant to the competitive evaluation process, information collected facilitates RUS' selection of those applications most consistent with DLT goals and objectives in accordance with the authorizing legislation and implementing regulation.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2.45 hours per response.

Respondents: Business or other forprofit; not-for-profit institutions; and State, Local or Tribal Government.

Estimated Number of Respondents: 210.

Estimated Number of Responses per Respondent: 23.33.

Estimated Total Annual Burden on Respondents: 12,788 hours.

Since the Preliminary Determination, the Department conducted sales and factors of production (“FOP”) verifications for Beijing Tianhai Industry Co., Ltd. (“BTIC”), the mandatory respondent, from January 9 through January 17, 2012, and a sales verification for American Fortune Company (“AFC”), BTIC's U.S. affiliate, on February 9 and 10, 2012. 2 See the “Verification” section below for additional information. On January 31, 2012, and February 10, 2012, we received surrogate value (“SV”) comments from both BTIC and Petitioner and rebuttal SV comments from BTIC. On March 2, 2011, we issued a post-preliminary supplemental questionnaire.

Upon the February 23, 2012, release of the verification reports, we invited interested parties to comment on the Preliminary Determination. On March 6, 2012, we received case briefs from Petitioner, 3 BTIC, and Zhejiang Jindun Pressure Vessel Co., Ltd. (“Jindun”). On March 26, 2012, we received rebuttal briefs from Petitioner and BTIC. On March 16, 2012, we released a new labor calculation and requested that interested parties submit comments. 4 On March 26, 2012, BTIC submitted comments regarding the revised labor calculation. The Department held a public hearing on April 4, 2012, pursuant to 19 CFR 351.310(d).

All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the “Antidumping Duty Investigation of High Pressure Steel Cylinders from the People's Republic of China: Issues and Decision Memorandum for the Final Determination” (“Decision Memorandum”), dated concurrently with this notice and which is hereby adopted by this notice. A list of the issues which parties raised, and to which we respond to in the Decision Memorandum, is attached to this notice as Appendix I. The Decision Memorandum is a public document and is on file electronically via Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System (“IA ACCESS”). Access to IA ACCESS is available in the Central Records Unit (“CRU”), room 7046 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the internet at http://www.trade.gov/ia/. The signed Decision Memorandum and the electronic versions of the Decision Memorandum are identical in content.

Based on our analysis of information on the record of this investigation, we have made changes regarding BTIC and the separate rate companies  5 for the final determination.

• Subsequent to the Preliminary Determination, at the Department's request, BTIC provided a revised FOP and sales database.

• We have changed the source used for valuing truck freight.

• We have changed the surrogate financial statements upon which we are relying to calculate financial ratios from Everest Kanto Cylinder Ltd. to Thai Metal Drum Manufacturing Public Company Limited.

• We have excluded water and all of the other energy FOPs from the build-up for normal value as the Thai Metal Drum Manufacturing Public Company Limited financial statement does not provide sufficient detail for the Department to allocate those factors appropriately.

• We are changing the date of sale for constructed export price (“CEP”) sales to reflect the correct date of sale in the “Targeted Dumping” section of the margin calculation program.

• We are using the revised labor valuation methodology discussed in our March 16, 2012, memorandum. 6

• In the Preliminary Determination, we assigned the PRC-wide rate of 26.23 percent, the highest transaction-specific rate preliminarily calculated for BTIC. For this final determination, we continue to use BTIC's highest transaction-specific rate, which now is 31.42 percent.

The merchandise covered by the scope of the investigation is seamless steel cylinders designed for storage or transport of compressed or liquefied gas (“high pressure steel cylinders”). High pressure steel cylinders are fabricated of chrome alloy steel including, but not limited to, chromium-molybdenum steel or chromium magnesium steel, and have permanently impressed into the steel, either before or after importation, the symbol of a U.S. Department of Transportation, Pipeline and Hazardous Materials Safety Administration (“DOT”) approved high pressure steel cylinder manufacturer, as well as an approved DOT type marking of DOT 3A, 3AX, 3AA, 3AAX, 3B, 3E, 3HT, 3T, or DOT-E (followed by a specific exemption number) in accordance with the requirements of sections 178.36 through 178.68 of Title 49 of the Code of Federal Regulations, or any subsequent amendments thereof. High pressure steel cylinders covered by the investigation have a water capacity up to 450 liters, and a gas capacity ranging from 8 to 702 cubic feet, regardless of corresponding service pressure levels and regardless of physical dimensions, finish or coatings.

Excluded from the scope of the investigation are high pressure steel cylinders manufactured to UN-ISO-9809-1 and 2 specifications and permanently impressed with ISO or UN symbols. Also excluded from the investigation are acetylene cylinders, with or without internal porous mass, and permanently impressed with 8A or 8AL in accordance with DOT regulations.

Merchandise covered by the investigation is classified in the Harmonized Tariff Schedule of the United States (“HTSUS”) under subheading 7311.00.00.30. Subject merchandise may also enter under HTSUS subheadings 7311.00.00.60 or 7311.00.00.90. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise under the investigation is dispositive.

As provided in section 782(i) of the Act, we conducted verification of the information submitted by BTIC for use in our final determination. We used standard verification procedures, including examination of relevant accounting and production records, as well as original source documents provided by BTIC. 7

Background: The Council was re-chartered on April 5, 2012 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry.

Topics To Be Considered: The Council will be conducting work regarding possibly advising the Secretary regarding the Trans-Pacific Partnership Agreement negotiations and energy policy and hear updates on the work being conducted by the Council's subcommittees. The Council will also be briefed by the ex-officio members present representing the Secretaries of the Treasury, Labor, and Energy on their respective agency's work in the areas of past Council recommendations.

No time will be available for oral comments from members of the public attending the session. Any member of the public may submit pertinent written comments concerning the Council's affairs at any time before or after the session.

Comments may be submitted to Jennifer Pilat at the contact information indicated above. To be considered during the session, comments must be received no later than 5:00 p.m. Eastern Time on May 7, 2012, to ensure transmission to the Council prior to the session.

Comments received after that date will be distributed to the members but may not be considered at the session.

I. Abstract

This request is for extension of a currently approved information collection.

Under the provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ), NOAA's National Marine Fisheries Service (NMFS) is responsible for management of the nation's marine fisheries. Existing regulations require operators of tournaments involving Atlantic highly migratory species (HMS), specifically Atlantic swordfish, sharks, billfish, and tunas, to register four weeks in advance of the tournament. Operators must provide contact information and the tournament's date(s), location(s), and target HMS. If selected by NMFS, operators are required to submit an HMS tournament summary report within seven days after tournament fishing has ended. Most of the catch data in the summary report is routinely collected in the course of regular tournament operations. NMFS uses the data to estimate the total annual catch of HMS and the impact of tournament operations in relation to other types of fishing activities. In addition, HMS tournament registration provides a method for tournament operators to request educational and regulatory outreach materials from NMFS.

Operators have a choice of either electronic or paper forms. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.

OMB Control Number: 0648-0323.

Form Number: None.

Type of Review: Regular submission (extension of a current information collection).

Affected Public: Not-for-profit institutions; business or other for-profit organizations.

Estimated Number of Respondents: 300.

Estimated Time Per Response: Tournament registration, 2 minutes; tournament summary reporting, 20 minutes.

Estimated Total Annual Burden Hours: 110.

Estimated Total Annual Cost to Public: $135 in recordkeeping/reporting costs.

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 shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (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 respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The Southeast Alaska purse seine salmon fishery is a commercial fishery in Alaska state waters and adjacent Federal waters. It encompasses the commercial taking of salmon with purse seine gear, and participation is limited to fishermen designated by the Alaska Commercial Fisheries Entry Commission (CFEC).

NMFS published proposed program regulations on May 23, 2011 (76 FR 29707), and final program regulations on October 6, 2011 (76 FR 61986), to implement the reduction program. Subsequently, the Southeast Revitalization Association submitted a capacity reduction plan to NMFS. NMFS approved the plan on February 24, 2012. NMFS published the list of eligible voters on March 1, 2012 (77 FR 12568) and the notice of referendum period on March 29, 2012 (77 FR 19004). Interested persons should review these for further program details.

NMFS conducted a referendum to determine the industry's willingness to repay a fishing capacity reduction loan to purchase the permits identified in the reduction plan. NMFS mailed ballots to 379 permanent permit holders in the fishery designated as S01A by CFEC who were eligible to vote in the referendum. The voting period opened on March 30, 2012, and closed on April 30, 2012. NMFS received 269 timely and valid votes. 215 of the votes approved the fees. This exceeded the majority of permit holders (190) required for industry fee system approval. Therefore, the referendum is deemed successful and permit holders are deemed to have approved the industry fee system. Accordingly, the reduction contracts are in full force and effect and NMFS is now preparing to tender and disburse reduction payments to selected bidders.

NMFS publishes this notice to inform the public before tendering reduction payments to the 64 accepted bidders. Upon receiving notice from CFEC that the permit has been relinquished and is no longer valid, NMFS will tender reduction payments on or about June 6, 2012. When NMFS tenders a reduction payment to a selected bidder, the selected bidder must permanently stop all further fishing represented by each reduction permit the bidder has relinquished. The selected bidder, in accordance with section 5 of the relinquishment contract, must notify all creditors or other parties with security interests in the reduction permit, that they have entered into the relinquishment contract.

This notice provides the public (including creditors or other parties) 30 days from publication of this notice to advise NMFS in writing of any holding, owning, or retaining claims that conflict with the representations of bids as presented by the SRA.

The table below lists the 64 permit holders who will receive reduction payments when NMFS receives confirmation from CFEC that the specified permits have been relinquished.

As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, notice is hereby given of a meeting of MAFAC. The MAFAC was established by the Secretary of Commerce (Secretary), and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete charter and summaries of prior meetings are located online at http://www.nmfs.noaa.gov/ocs/mafac/.

This agenda is subject to change.

The meeting is convened to hear presentations and discuss policies and guidance on the following topics: NMFS budget and legislative issues, aquaculture policy implementation and the Washington State aquaculture initiative, National Standard 1 advanced notice of proposed rulemaking, fisheries certification and sustainability, working waterfronts, revisions to MAFAC's Vision 2020 report, and current protected resources issues. Updates will be presented on Gulf of Mexico restoration activities, National Ocean Policy, recreational fisheries initiatives, and outlooks for 2012 regulatory and science activities. The meeting will include discussion of various MAFAC administrative and organizational matters and meetings of the standing subcommittees.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mark Holliday, MAFAC Executive Director; 301-427-8004 by May 16, 2012.

The ABC Control Rule Working Group will meet to review the results of applying the Ralston et al. (2011) method of calculating ABC when the variances used are computed from GOM stocks, to review discussion on linking Tier 3 ABCs to data collection actions, continue reviews and edits to the ABC control rule, and decide what recommendation to carry forward to the Scientific and Statistical Committee for its June 2012 meeting.

Copies of the agenda and other related materials can be obtained by calling (813) 348-1630. Materials will also be available to download from the ABC Control Rule Working Group folder of the Council's FTP site, which is accessible from the Quick Links section of the Council Web site ( http://www.gulfcouncil.org ).

Although other non-emergency issues not on the agenda may come before the ABC Control Rule Working Group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Working Group will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

This webinars are accessible to people with disabilities. For assistance with any of our webinars contact Kathy Pereira at the Council (see ADDRESSES ) at least 5 working days prior to the webinar.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR includes three workshops: (1) Data Workshop, (2) Stock Assessment Workshop and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Stock Assessment Workshop is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Consensus Summary documenting Panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

SEDAR 30 Workshop Schedule:

July 17-19, 2012: 3 p.m.-7 p.m.

An assessment data set and associated documentation will be developed during the Data Scoping Workshops. Participants will evaluate available data and select appropriate sources for providing information on life history characteristics, catch statistics, discard estimates, length and age composition, and fishery dependent and fishery independent measures of stock abundance.

October 16-18, 2012: 9 a.m.-8 p.m.

Using datasets provided by the Data Scoping Workshops, participants will develop population models to evaluate stock status, estimate population benchmarks and stock status criteria, and project future conditions. Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters. Participants will prepare a workshop report, compare and contrast various assessment approaches, and determine whether the assessments are adequate for submission to the review panel.

February 4, 2013: 1 p.m.-8 p.m.; February 5-7, 2013: 8 a.m.-8 p.m.

The Review Workshop is an independent peer review of the assessment developed during the Data and Assessment Workshops. Workshop Panelists will review the assessment and document their comments and recommendations in a Consensus Summary.

The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from, or completed prior to the time established by this notice.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 10 business days prior to each workshop.

The subject amendment to Permit No. 15748 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

Permit No. 15748, issued on May 25, 2011 (76 FR 31942), authorizes the permit holder to capture and harass free-living Weddell seals ( Leptonychotes weddellii ) in McMurdo Sound and along the shore of Ross Island, Antarctica to study thermoregulation. The research involves capture and restraint of adult females and pups/juveniles of either sex for attachment of scientific instruments, morphometric measurements, ultrasound, and tissue sampling. Harassment of additional seals in the vicinity of captured animals is also authorized, as is research-related mortality. Tissue samples collected may be exported from Antarctica for analysis in the U.S. The permit is valid through August 30, 2015.

The permit holder is requesting the permit be amended to include changes to the terms and conditions of the permit related to numbers of animals taken and manner of taking to include: increasing takes for the deployment of instrumentation on weaned pups/juveniles from 20 over the life of the permit to 35 over the life of the permit; increasing the number of takes per animal of weaned pups/juveniles and adult females from 2 to 3; adding nasal, oral, and rectal swab collection (one of each per animal) in weaned pups/juveniles and adult females; adding the use of spray lidocaine or similar agent; adding stable isotope analysis to compare stable isotope values of Weddell seals in the Ross Sea in the early 1900s to today; and adding an influenza A analysis using the requested swab collection to understand the exposure of pathogens to Antarctic marine mammals.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of this application to the Marine Mammal Commission and its Committee of Scientific Advisors.

In accordance with section 10(d) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App. 2) and 41 CFR 102-3.155, the Department of Defense has determined that these Defense Science Board quarterly meetings will be closed to the public. Specifically, the Under Secretary of Defense (Acquisition, Technology and Logistics), with the coordination of the DoD Office of General Counsel, has determined in writing that all sessions of these meetings will be closed to the public because they will be concerned throughout with matters listed in 5 U.S.C. 552b(c)(1) and (4). Interested persons may submit a written statement for consideration by the Defense Science Board. Individuals submitting a written statement must submit their statement to the Designated Federal Official at the address detailed in FOR FURTHER INFORMATION CONTACT , at any point; however, if a written statement is not received at least 10 calendar days prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Defense Science Board. The Designated Federal Official will review all timely submissions with the Defense Science Board Chairperson, and ensure they are provided to members of the Defense Science Board before the meeting that is the subject of this notice.

Under the provisions of section 10(d) of Public Law 92-463, the Department of Defense has determined that the meetings meet the criteria to close meetings to the public because the matters to be considered are related to internal rules and practices of the Department of Defense and the detailed wage data to be considered were obtained from officials of private establishments with a guarantee that the data will be held in confidence.

However, members of the public who may wish to do so are invited to submit material in writing to the chairman concerning matters believed to be deserving of the Committee's attention.

Under the provisions of section 10(d) of Public Law 92-463, the Department of Defense has determined that the meetings meet the criteria to close meetings to the public because the matters to be considered are related to internal rules and practices of the Department of Defense and the detailed wage data to be considered were obtained from officials of private establishments with a guarantee that the data will be held in confidence.

However, members of the public who may wish to do so are invited to submit material in writing to the chairman concerning matters believed to be deserving of the Committee's attention.

The Board shall meet at the call of the Designated Federal Officer, in consultation with the Board's Chairperson. The estimated number of Board meetings is two per year.

In addition, the Designated Federal Officer is required to be in attendance at all Board and subcommittee meetings for the entire duration of each and every meeting; however, in the absence of the Designated Federal Officer, the Alternate Designated Federal Officer shall attend the entire duration of the Board or subcommittee meeting.

Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Chief of Engineers Environmental Advisory Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Chief of Engineers Environmental Advisory Board.

All written statements shall be submitted to the Designated Federal Officer for the Chief of Engineers Environmental Advisory Board, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Chief of Engineers Environmental Advisory Board Designated Federal Officer can be obtained from the GSA's FACA Database— https://www.fido.gov/facadatabase/public.asp.

The Designated Federal Officer, pursuant to 41 CFR 102-3.150, will announce planned meetings of the Chief of Engineers Environmental Advisory Board. The Designated Federal Officer, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.

This information collection request contains: (1) OMB No. 1910-5143; (2) Information Collection Request Title: Labor Relations. This information collection was originally titled Legacy Management Labor Relations, but due to transfer of this function to the Office of General Counsel, the title has been shortened to Labor Relations; (3) Type of Review: Renewal; (4) Purpose: To obtain information from the Department of Energy Management and Operation, and Facilities Management Contractors for contract administration, management oversight and cost control; (5) Annual Estimated Number of Respondents: 35; (6) Annual Estimated Number of Total Responses: 35; (7) Annual Estimated Number of Burden Hours: 193; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $0.00 annually.

Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

1. Evaluate 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.

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. 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, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the collection activity.

7. Make sure to submit your comments by the deadline identified under DATES .

8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

Affected entities: Entities potentially affected by this ICR are companies that export from the United States to foreign countries, or that engage in wholesale sales of, chemical substances or mixtures.

Title: Notification of Chemical Exports—TSCA Section 12(b).

ICR number: EPA ICR No. 0795.14.

OMB control number: OMB Control No. 2070-0030.

ICR status: This ICR is currently scheduled to expire on March 31, 2013. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: Section 12(b)(2) of the Toxic Substances Control Act (TSCA) requires that any person who exports or intends to export to a foreign country a chemical substance or mixture that is regulated under TSCA sections 4, 5, 6, and/or 7 submit to EPA notification of such export or intent to export. Upon receipt of notification, EPA will advise the government of the importing country of the U.S. regulatory action with respect to that chemical substance or mixture. EPA uses the information obtained from the submitter via this collection to advise the government of the importing country. This information collection addresses the burden associated with industry reporting of export notifications.

Responses to the collection of information are mandatory (see 40 CFR part 707). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 1.3 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR provides a detailed explanation of this estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 240.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 12.9.

Estimated total annual burden hours: 4,025 hours.

Estimated total annual costs: $245,246. This includes an estimated burden cost of $245,246 and an estimated cost of $0 for capital investment or maintenance and operational costs.

There is a decrease of 825 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects the net effect of a decrease in the estimated number of TSCA section 12(b) notices sent to EPA and a decrease in the number of firms sending notices, based on EPA's recent experience with those submissions. This change is an adjustment.

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT .

Environmental protection, Chemicals, Exports, Reporting and recordkeeping requirements.