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有关FDA食品生产安全规则的FAQs:蔬菜是否要在销售之前冻结才能获得豁免? 临安科达认证技术咨询服务有限公司   时间:2018-04-25   点击:1940 次
PSR.2 What produce is covered by this rule,and what produce is not covered? 这个规则涵盖什么产品,什么产品不包括在内? All types of produce are covered by the rule except as provided by specificexemptions from the rule. Exemptions include produce that: 所有类型的产品都被规则所涵盖

 

PSR.1 What are the key requirements andcompliance dates?

关键要求和合规日期是什么?

More information about the final rule can be found in the ProduceSafety At-a-Glance fact sheet.

有关最终法规的更多信息,请参见生产安全概览一览表。


PSR.2 What produce is covered by this rule,and what produce is not covered?

这个规则涵盖什么产品,什么产品不包括在内?

All types of produce are covered by the rule except as provided by specificexemptions from the rule. Exemptions include produce that:

所有类型的产品都被规则所涵盖,除了规定提供的具体豁免。豁免包括:

·        is grown for personal or on-farm consumption

·        种植用于个人或农场消费


·        Is not a “raw agricultural commodity.” (A raw agriculturalcommodity is any food in its raw or natural state)

·        不是“原始农产品”(原始农产品是天生的或天然的食物状态)


·        will receive commercial processing that adequately reducesmicroorganisms of public health concern (e.g., through use of a “kill step”) iseligible for exemption under certain conditions (including keeping certaindocumentation).

·        在某些条件下(包括保存某些文件)将充分减少公共卫生微生物的商业处理(例如,通过使用“破坏步骤”)有资格获得豁免。


·        is on the “rarely consumed raw” list. The “rarely consumedraw” list is exhaustive and contains the following fruits and vegetables:asparagus; black beans, great Northern beans, kidney beans, lima beans, navybeans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews;sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn;cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish;hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins;winter squash; sweet potatoes; and water chestnuts.

·        在“很少消费的原料”列表。“很少消费的原料”列表是详尽无遗的,包含以下水果和蔬菜:芦笋;黑豆,大北豆,芸豆,利马豆,海军豆和扁豆;花园甜菜(根和顶)和甜菜;腰果;酸樱桃鹰嘴豆;可可豆;咖啡豆;甘蓝;甜玉米;蔓越莓;海枣;莳萝(种子和杂草);茄子;无花果;辣根;榛子;扁豆;秋葵;花生;胡桃;薄荷;土豆;南瓜;冬季南瓜;红薯和栗子。


o   The content of this list in the final rule is somewhatdifferent from the proposed version. These changes were made in response topublic comments and based on FDA’s analysis of available data. For example,Brussels sprouts and kale were removed from the proposed list, and pecans wereadded to the final list.

o    最终法规中此列表的内容与建议版本有些不同。这些更改是根据公众意见进行的,并根据FDA对可用数据的分析。例如,布鲁塞尔芽菜和羽衣甘蓝从提议的清单中删除,山核桃被添加到最终名单。


PSR. 3 Are vegetables intended to be frozenprior to sale eligible for exemption?

蔬菜是否要在销售之前冻结才能获得豁免?

Not necessarily. Produce that receives commercial processing that adequatelyreduces the presence of pathogens of public health significance is eligible forexemption if other relevant requirements are met. Blanching and/or freezingprocesses may qualify if they are validated to ensure that the specificprocedures followed adequately reduce pathogens in the food.  

不必要。如果满足其他相关要求,可以获得充分减少具有公共卫生意义的病原体存在的商业处理的产品有资格获得豁免。如果经过验证以确保特定程序能够充分减少食品中的病原体,则热烫和/或冷冻过程可能有资格。


PSR.4 Why does the final rule containadditional requirements for sprout production?

为什么最终法规包含对芽菜生产的额外要求?

Sprouts are vulnerable to bacterial contamination because of the warm, moistand nutrient-rich conditions in which they grow. They have frequently beenassociated with outbreaks of foodborne illness. The Produce Safety final ruleincludes specific requirements in Subpart M for most sprouts. This subpart doesnot cover sprouts that are soil- or substrate-grown and are harvested withouttheir roots. All sprouts, including those not covered under Subpart M, arecovered produce subject to the other provisions of the produce rule asapplicable.

 由于其生长的温暖,潮湿和营养丰富的条件,芽菜易受细菌污染。它们经常与食源性疾病的爆发有关。生产安全最终法规包括对于大多数芽苗的子部分M中的具体要求。该子部分不包括土壤或底物生长并且没有根部的收获的芽苗。所有芽苗,包括不属于子部分M的那些,均适用于产品规则的其他规定。


PSR.5 Is extra time allowed for smallerfarms to come into compliance with the requirements? 

更小的农场要额外的时间来满足要求吗?

The FDA has staggered the compliance dates, based on the size of farms, toprovide additional time for small and very small farms to come into compliancewith the requirements, and is providing extended time for almost all farms tomeet certain water requirements in Subpart E. Because of their history ofoutbreaks, operations growing sprouts have less time to come into compliancethan other farms and do not get additional time to come into compliance withany of the water requirements. Farms with an average annual value of producesold of $25,000 or less during the previous three year period are not coveredby the rule. 

FDA根据农场规模,为小型和非常小的农场提供额外的时间来符合要求,并为几乎所有农场提供延长时间以满足子部分E中的某些用水要求。

由于其爆发的历史,生长发芽的过程与其他农场相比有更少的时间达标,并且没有额外的时间来符合任何水的需求。前三年平均年销售价值25000美元以下的农场不属于这一规定。


PSR. 6 What if farmers need helpmeeting these new requirements? 

如果农民需要帮助满足这些新要求呢?
The FDA has beenworking with the U.S. Department of Agriculture (USDA), state agriculturedepartments, the Produce Safety Alliance and the Sprouts Safety Alliance, aswell as others, to make sure there are numerous resources available fortraining, education and technical assistance to aid farmers with implementationof the Produce Safety rule. The agency is planning to use a number ofapproaches, including guidance documents, to give farmers the tools they needto comply with the new regulations. The agency recently released a trainingstrategy to support compliance with the FSMA rules.

FDA一直在与美国农业部(USDA),国家农业部门,生产安全联盟,芽菜安全联盟以及其他机构合作,确保有大量资源用于培训,教育和技术援助帮助农民实施生产安全规则。该机构正在计划采用一些方法,包括指导性文件,向农民提供遵守新规定所需的工具。该机构最近发布了一项培训战略,以支持遵守FSMA规则。


PSR.7 How does the FDA plan to determine howmuch time should be required between the application of raw manure and theharvest of produce covered by the rule?

FDA如何计划确定法规覆盖的原废料应用和农产品收获需要多少时间?
The FDA is deferringits decision on an appropriate time interval between the application ofuntreated biological soil amendments of animal origin, including manure, andharvest of covered produce until we pursue a risk assessment and research tosupplement the science on an appropriate interval. We anticipate that theseefforts will take five to 10 years to complete. Following the completion of therisk assessment and research work, we expect to: (1) provide stakeholders withdata and information gathered from scientific investigations and riskassessment; (2) consider such new data and information to develop tentativescientific conclusions; (3) provide an opportunity for public comment on ourtentative decisions; and (4) consider public input to finalize the provision(s)establishing an appropriate minimum application interval(s). The final producerule contains other requirements related to the safe use of biological soilamendments of animal origin, including raw manure, in Subpart F. For example,the rule establishes certain application method requirements for treated anduntreated biological soil amendments of animal origin.

  FDA正在推迟在未经处理的动物来源的生物土壤修复(包括粪便)和覆盖的产品的收获之间的适当时间间隔,直到我们进行风险评估和研究,以补充科学适当间隔。我们预计这些努力将需要五到十年才能完成。风险评估和研究工作完成后,我们期望:(1)向利益相关者提供从科学调查和风险评估中收集的数据和信息(2)考虑这些新的数据和信息来制定暂定的科学结论(3)对于我们暂时的决定提供公开评论的机会(4)考虑公众意见,确定适当的最短申请间隔。


  最终产品法规包含与安全使用动物来源的生物土壤修复(包括原始粪便)有关的其他要求。例如,该法规确定了对动物来源的处理和未经处理的生物土壤修复的某些应用方法要求。


PSR.8 What were the primary findings of theFinal Environmental Impact Statement (EIS) and Record of Decision (ROD)?

最终环境影响声明(EIS)和决策记录(ROD)的主要发现是什么?

In developing the Final Environmental Impact Statement (EIS), the FDAconsidered any adverse impacts that implementation of the proposed ProduceSafety rule provisions and various alternatives could potentially have on theenvironment. The agency is also required to prepare a public document, calledthe Record of Decision (ROD), to address how the EIS findings are incorporatedinto decisions about the final rule and the ROD further explains potentialimpacts on the environment that could result from the Produce Safety Rule, asfinalized. In the ROD, the agency explains how the provisions in the final rulebest meet FDA’s public health goals while minimizing environmental impacts asmuch as possible. The primary benefit of this rule is expected to be asignificant decrease in the number of foodborne illnesses every year. The rulehas the potential to significantly impact the environment as a result ofgroundwater drawdown. However, the flexibility that has been introduced intothe rule is expected to minimize the likelihood that this will occur. 

在制定最终环境影响报告书(EIS)时,FDA认为实施生产安全规则规定和各种替代品可能对环境有潜在的任何不利影响。该机构还需要编写一份称为决策记录(ROD)的公共文件,以解决EIS结果如何纳入关于最终法规的决定中,ROD进一步解释了可能从生产中产生的对环境的潜在影响安全规则,定稿。在ROD中,该机构解释了最终规法规中的规定如何最好地满足FDA的公共卫生目标,同时尽量减少对环境的影响。这一法规的主要好处是每年食源性疾病的数量预计将大大减少。该规则有可能由于地下水的下降而对环境产生显着影响。然而,已经引入规则的灵活性有望使发生这种情况的可能性最小化。


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